FDA 510(k) Applications for Medical Device:
Sunglasses (Non-Prescription Including Photosensitive)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K972246 | ALIMAR TRADING, INC. |
7220 N.W. 36TH ST., SUITE 102 | MIAMI | FL | 33166 |
| K954419 | AMI FASHION |
501-4 NOWON 3KA, BUK GU | DAEGU | 702-816 | |
| K974045 | AMSURE SPORTS, INC. |
1818 NAIO STREET, SUITE B | HONOLULU | HI | 96817 |
| K971249 | ANDREW G. HALPERN |
901 MAIN STREET, SUITE 4300 | DALLAS | TX | 75202 |
| K970744 | ANTI-RAY, INC. |
1030 WILLIAMSON AVE. | FULLERTON | CA | 92633 |
| K960573 | ARCHITECTURES |
605 THIRD AVE. | NEW YORK | NY | 10158 |
| K960530 | ARNET OPTIC ILLUSIONS |
927 CALLE NEGOCIO | SAN CLEMENTE | CA | 92673 |
| K963955 | BERT & JOE'S, INC. |
30140 HARPER AVE., STE. 300 | ST. CLAIR SHORES | MI | 48082 |
| K954659 | BLUBLOCKER CORP. |
3350 PALMS CENTER DR. | LAS VEGAS | NV | 89103 |
| K955933 | BUFFARD CREATION EURL |
BP 56 - 39402 | MOREZ CEDEX | ||
| K963630 | C.O.L.D.A. S.N.C. |
VIA ARCANE, 25 | VALDOBBIADENE (TV) | 31049 | |
| K965125 | CALIFORNIA DESIGN STUDIO, INC. |
5126 CLARETON DR. | AGOURA HILLS | CA | 91301 |
| K962775 | CANADD TRADING CO. |
RM817, SOHYUN BLD., #175 | DAEGU | ||
| K974852 | CHIA HUI SPECTACLES MFG. CORP. |
10 FU CHIANG RD., SEC. 1, | YUNG KANG CITY, TAINAN, HSIEN | ||
| K962436 | CHUNGSIN KAU OPTICAL MFY. CO. LTD. |
BLOCK C, NO. 7,8/F, WAH TAT | KWAI CHUNG | ||
| K962310 | CLASSIC ELEGANCE INTL., INC. |
20639 LYCOMING ST., #B-9 | DIAMOND BAR | CA | 91789 |
| K971495 | COIL |
1314 NORTH HUNTER ST. | BALTIMORE | MD | 21202 |
| K962478 | CUSTOM OPTICAL FRAMES, INC. |
11611 OLD GEORGETOWN RD. | ROCKVILLE | MD | 20852 |
| K970895 | CUSTOM OPTICAL FRAMES, INC. |
11611 OLD GEORGETOWN RD. | ROCKVILLE | MD | 20852 |
| K971462 | D.G. PROVE CO. |
22 KEELUNG RD., #6, 7TH FL., | TAIPEI | 110 | |
| K960798 | D&K STORES, INC. |
2125 HIGHWAY 35 | OAKHURST | NJ | 07755 |
| K960797 | D&K STORES, INC. |
2125 HIGHWAY 35 | OAKHURST | NJ | 07755 |
| K970101 | D&K STORES, INC. |
2125 ROUTE 35 | OAKHURST | NJ | 07755 |
| K955695 | DAH SING TRADING CO. |
UNIT 901, 9/F., FORTUNE COMM. | TSUEN WAN | ||
| K971104 | DELAGAR DIVISION BELCAM, INC. |
27 MONTGOMERY ST. | ROUSES POINT | NY | 12979-0277 |
| K955572 | DIAMOND MARK INTERNATIONAL CO., LTD. |
HOPING EAST RD., SEC. 3 | TAIPEI | ||
| K961523 | DORDA TOYS |
2546 CORPORATE PLACE | MONTEREY PARK | CA | 91754 |
| K971551 | DUQIAO GLASSES (GROUP) CO. LTD. |
279 FUQIAN STREET, DUQIAO | LINHAI, ZHEJIANG | ||
| K973934 | ELEGANCE OPTICAL MANUFACTORY, LTD. |
401 BROADWAY, SUITE 613 | NEW YORK | NY | 10013 |
| K970816 | ERGOVISION, INC. |
ONE FAIRCHILD COURT | PLANVIEW | NY | 11803 |
| K961146 | ERICA OPTICAL CO. |
11611 OLD GEORGETOWN RD. | ROCKVILLE | MD | 20852 |
| K961746 | EUROTRENDS EYEWEAR, INC. |
1702 OLD MINTERS CHAPEL RD. | GRAPEVINE | TX | 76051 |
| K964413 | EVER PRIME ENTERPRISES LTD. |
18 JAVA ROAD | NORTH POINT | ||
| K960735 | EVERGLORY CREATIONS, INC. |
11 FL., 36, | TAPEL | R.O.C. | |
| K971326 | EXCEL EYEWEAR CORP. |
2 NORTHEAST 40TH ST., | MIAMI | FL | 33137 |
| K971327 | EYEWEAR PARTNERS CO. |
2 NORTHEAST 40TH ST. | MIAMI | FL | 33137 |
| K960786 | FABRIS LANE INTL., LTD. |
DAVIS RD. | CHESSINGTON, SURREY | KT9 1TT | |
| K963075 | FRAMESMART, INC. |
8666 N.W. 58TH ST. | MIAMI | FL | 33166-3306 |
| K962912 | FRAMESMART, INC. |
8666 N.W. 58TH ST. | MIAMI | FL | 33166-3306 |
| K960950 | FRANCO SORDELLI & C. SNC |
VIA 4 NOVEMBRE 12 | VENEGONO INF. (VARESE) | 21040 | |
| K960953 | GALILEE OPTICS |
11611 OLD GEORGETOWN RD. | ROCKVILLE | MD | 20852 |
| K955611 | GATORZ L.L.C. |
5384 LINDA VISTA RD. #104 | SAN DIEGO | CA | 92110 |
| K962636 | GAUDI SPA |
162 E. BROADWAY ST. | OVIEDO | FL | 32765 |
| K974441 | HIP SHING FAT CO., LTD. |
1829-1832 STAR HOUSE, TST | KOWLOON | ||
| K970476 | HWA MAO OPTICAL CO., LTD. |
HUA SHENG ROAD | HU LI, XIAMEN | ||
| K964505 | I C OPTICS, LTD. |
366 FIFTH AVE., SUITE 1003 | NEW YORK CITY | NY | 10001 |
| K972850 | INDOPTICA, S.A. |
1275 BEECHNUT PLACE, SUITE A | POMONA | CA | 91766 |
| K961286 | INTL. OPTICAL MFG. CO., LTD. |
100-102 KING FUK ST., FLAT C&D | SAN PO KONG, KOWLOON | ||
| K961603 | INTROMARK, INC. |
217 NINTH ST. | PITTSBURGH | PA | 15222-3506 |
| K963890 | ITALIAN EYEWEAR, INC. |
7220 NW 36TH ST. | MIAMI | FL | 33166 |
| K960289 | JAMES KOREA CO., LTD. |
P.O. BOX 162021 | MIAMI | FL | 33116-2021 |
| K962279 | JANE FUI OPTICAL CO., LTD. |
7 SHIN HO RD. | TAINAN | ||
| K973528 | JEOU JEOU LONG INDUSTRIAL CO., LTD. |
7 CHIEH MIN RD., LANE 285 | KAOHSIUNG | ||
| K971385 | KOSWAY INDUSTRIES CO., LTD. |
7/8/10/12 KIN FAT ST., BLK. B, | TUEN MUN, N.T. | ||
| K961034 | KYLIE ENTERPRISE CO. LTD. |
MIN-LO ST., NO.3, 3RD. FL., | YUNG-HO, TAIPEI HSIEN | ||
| K960628 | LANARD TOYS, LTD. |
6/F ENERGY PLAZA | TSIMSHATSUI | ||
| K970454 | LAXIMA INTL., LTD. |
15-25 CHIU LUNG ST., 2ND FL. | CENTRAL HONG KONG | ||
| K972590 | LBI U.S.A. |
20801 NORDHOFF ST. | CHATSWORTH | CA | 91311 |
| K962107 | LEONACHI, INC. |
5943 BISCAYNE BLVD. | MIAMI | FL | 33137 |
| K971384 | LONG IN TIME ENT. CO., LTD. |
NO. 7 ALLEY 500 LN. 942 TAI | TAINAN HSIEN | ||
| K963968 | LOOK STYLE, S.R.L. |
VIA S. GIOVANNI N. 56 | CALALZO DI CADORE, (BL) | 32042 | |
| K972490 | M & R DIST. |
1219 SUNSET PLAZA DR., #4 | LOS ANGELES | CA | 90069 |
| K964366 | MECH-TRONIC PRECISION MFG.,LTD. |
FLAT 4, 9/F., FU NGA HOUSE | KOWLOON | ||
| K964316 | MEDICAL REPORTS EXCHANGE, INC. |
2112 CROSS TRAILS RD. | BALTIMORE | MD | 21244 |
| K961035 | MI TECHNOLOGIES, INC. |
116 EAST MONTGOMERY AVE., #410 | ARDMORE | PA | 19003 |
| K965170 | MICHELANGELO, INC. |
2901 COMMERCE PARK DR. | BOYNTON BEACH | FL | 33426 |
| K964943 | MICRON EYEWEAR MANUFACTORY CO., LTD. |
UNIT 20, 5/F, WELL FUNG IND. | KWAI CHUNG, N.T. | ||
| K964564 | MICRON METAL & PLASTIC MANUFACTORY CO. |
UNIT 20, 5/F, WELL FUNG IND. | KWAI CHUNG N.T. | ||
| K962298 | MIRAGE EYEWEAR, INC. |
961 MERIDIAN AVE. | ALHAMBRA | CA | 91803 |
| K960668 | MISTRAL OPTICAL |
VIA DEL FAGHER ZONA | QUERO BELLUNO | 32030 | |
| K972416 | MOMO U.S.A., INC. |
2100 N.W. 93RD. AVE. | MIAMI | FL | 33172 |
| K974414 | MORNING CALM CORP. |
1106 SEONG AN OFFICETEL | DAEGU | ||
| K970759 | MORRIS ROSENBLOOM & CO., INC. |
MIDTOWN TOWER | ROCHESTER | NY | 14804 |
| K964082 | NEO VU, INC. |
122 WEST 27TH ST. | NEW YORK | NY | 10001 |
| K962169 | NIKE, INC. |
ONE BOWERMAN DR. | BEAVERTON | OR | 97005-6453 |
| K962412 | NIKE, INC. |
10001 G STREET, N.W. | WASHINGTON | DC | 20001 |
| K971707 | NIKO SUNGLASSES CORP. |
401 SOUTH LOS ANGELES ST., #2 | LOS ANGELES | CA | 90013 |
| K961268 | OAKLEY, INC. |
10 HOLLAND | IRVINE | CA | 92718 |
| K973016 | OPTIMAXX INTL. |
10 VOLVO DR. | ROCKLEIGH | NJ | 07647 |
| K960890 | OUTDOOR ACTION WEAR SPECIALTIES |
141 W. JACKSON BLVD. | CHICAGO | IL | 60604 |
| K973407 | PACIFIC OPTICAL CO. LTD. |
#90, HONG DIAN RD., SOUTH | WENZHOU, ZHEJIANG | 325003 | |
| K963083 | PIAZZA OPTICAL CORP. |
12955 BISCAYNE BLVD., #314 | NORTH MIAMI | FL | 33181 |
| K962287 | POSITIVE RESPONSE TELEVISION |
EAST TOWER, SUITE 600 | SANTA MONICA | CA | 90404 |
| K973526 | PYRAMID HANDBAGS, INC. |
100 W. 33RD ST., SUITE 800 | NEW YORK | NY | 10001 |
| K963284 | RAVEN EYE, INC. |
3333 EARHART, SUITE 200 | CARROLLTON | TX | 75006 |
| K962940 | RAVEN EYE, INC. |
3333 EARHART, SUITE 200 | CARROLLTON | TX | 75006 |
| K972194 | RIVIERA OPTICAL CO., LTD. |
1314 NORTH HUNTER ST. | BALTIMORE | MD | 21202 |
| K961990 | ROKKO STARS CO., LTD. |
CENTRAL P.O. BOX 1156 | KOBE | ||
| K972717 | RUFF HOUSE, INC. |
136 COMMONWEALTH RD. | ROCHESTER | NY | 14618 |
| K970944 | SENTINAL IMPORTING CORP. |
125 CHARLES ST. | NORTH VANCOUVER, B.C. | V7H 1S1 | |
| K960650 | SOLOVISION OPTICAL, INC. |
2 N.E. 40TH ST. | MIAMI | FL | 33137 |
| K962725 | SOMA INTERNATIONAL LTD. |
75 MODY ROAD, TST EAST | KOWLOON | ||
| K964058 | SPENCER PRODUCTS CO. |
1533 EAST DEL AMO BLVD. | CARSON | CA | 90746 |
| K955539 | STEVEN CHEN |
5400 E. 21ST ST. #616 | WICHITA | KS | 67208 |
| K974511 | SUN WORLD INTL., INC. |
316 ROOSEVELT AVE. | FRANKLIN SQUARE | NY | 11010 |
| K972362 | SUNGLASS CITY, INC. |
7220 N.W. 36TH ST., SUITE 309 | MIAMI | FL | 33166 |
| K963059 | SUNQUEST INTL., INC. |
8-1 CHUNG-HSIAO EAST RD., 1/F, | TAIPEI | ||
| K971644 | SUUNTO USA |
2151 LAS PALMAS DR., SUITE G | CARLSBAD | CA | 92009 |
| K974179 | TAIPAN OPTICAL COMPANY LTD. |
18 TAK FUNG ST., SUITE 1702 | KOWLOON | ||
| K972014 | TAMFORT, LTD. |
420 FIFTH AVE. | NEW YORK | NY | 10018 |
| K971875 | TAYLOR/FOX ENTERPRISES, LLC. |
1730 PENNSYLVANIA AVE. NW | WASHINGTON | DC | 20006 |
| K971412 | TEAM CHIEN INDUSTRIAL CO., LTD. |
NO. 34-1 HSIN FU TSUN, HSI | TAINAN HSIEN | ||
| K943145 | THE MONTICELLO GROUP, INC. |
101 E. MONTICELLO PKWY. | STRAFFORD | MO | 65757 |
| K973490 | TONG YANG OPTICAL CO. |
C.P.O. BOX 193 | DAEGU | 700-600 | |
| K964429 | TRADE RESOURCES LTD. |
141 W. JACKSON BLVD. | CHICAGO | IL | 60604 |
| K964744 | TRANS-AMERICA ENTERPRISES CORP. |
3900 N.W. 79TH AVE. SUITE 484 | MIAMI | FL | 33166 |
| K965021 | VICTORY EYEWEAR CO., LTD. |
961 MERIDIAN AVE. | ALHAMBRA | CA | 91803 |
| K970538 | VICTORY EYEWEAR CO., LTD. |
NO.8 LANE 279 CHUNG CHENG RD | YUNG KANG CITY, TAIWAN HSIEN | ||
| K960818 | VISARD SRL |
VIA FELTRINA, 18 | BELLUNO | ||
| K961117 | VISARD SRL |
VIA FELTRINA, 18 | BELLUNO | ||
| K961128 | VISION-PRO INDUSTRIAL, LTD. |
106 HOW MING ST., ROOM 801 | KWUN TONG, KOWLOON | ||
| K971087 | W.J. BYRNES & CO. OF LOS ANGELES, INC. |
5777 W. CENTURY BLVD #360 | LOS ANGELES | CA | 90045 |
| K974861 | WENZHOU HINDAR OPTICAL CO., LTD. |
NO. 46-5 LIMING MID RD. | WENZHOU CITY | ||
| K974860 | WENZHOU MING MING OPTICAL CO. , LTD. |
NO. 11 HONFU LN. HON DIAN N.RD | WENZHOU, SHEJIANG | ||
| K962382 | XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. |
23 SHIN YUNG ROAD | XIAMEN, FUCHIEN | ||
| K970315 | YCC INTERNATIONAL CORP. |
1330 PONDEROSA DR. | MOSCOW | ID | 83843 |
| K970699 | YEONG JIUH CORP. |
NO. 73-6, 31 LIN, | CHU-PEI, HSINCHU | ||
| K955287 | YUU YENG ENTERPRISE CO., LTD. |
1ST FL. NO. 174, | TAINAN | 510850 | |
| K955441 | ZONG RONG GLASSES LTD. CO. |
1 FL., NO. 174 | TAINAN |
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