FDA 510(k) Applications for Medical Device:
Case, Contact Lens
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971618 | ALCON LABORATORIES |
6201 S FREEWAY | FT WORTH | TX | 76134 |
| K974281 | ALCON LABORATORIES |
6201 SOUTH FREEWAY | FORT WORTH | TX | 76134-2099 |
| K173538 | Alcon Laboratories, Inc. |
6201 South Freeway | Fort Worth | TX | 76134-2099 |
| K111856 | APOTHECARY PRODUCTS, INC. |
11750 12TH AVE. SOUTH | BURNSVILLE | MN | 55337 |
| K120969 | ARLINGTON CONTACT LENS SERVICES,INC. |
1468 HARWELL AVE. | CROFTON | MD | 21114 |
| K173365 | Bausch & Lomb Incorporated |
1400 North Goodman Street | Rochester | NY | 14609 |
| K013232 | BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. | ROCHESTER | NY | 14609 |
| K991206 | BONASSE ENT. CO., LTD. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K041820 | CIBA VISION CORPORATION |
11460 JOHNS CREEK PARKWAY | DULUTH | GA | 30097 |
| K160005 | DANYANG CHANXIN GLASSES CASES FACTORY |
HUADIAN CHUANGYE PARK, DANGUI ROAD, DEVELOPING ZONE | DANYANG CITY | 212300 | |
| K171539 | E-Link Plastic & Metal Industrial Co.,Ltd |
No.69-40, Hsing Shuh Rd. | New Taipei | 24262 | |
| K040914 | EXERO PRODUCTS, INC. |
623 GLACIER DRIVE | GRAND JUNCTION | CO | 81503 |
| K112832 | EYE CARE AND CURE |
4646 S OVERLAND DR | TUCSON | AZ | 85714 |
| K171163 | FiftyTwoWays Ltd |
Unit 4, 7th Floor, Flat B, Grand Ind. Bldg, 159-165 | Kwai Chung | ||
| K131875 | FORESIGHT REGULATORY STRATEGIES |
187 BALLARDVALE STREET | WILMINGTON | MA | 01887-4461 |
| K042578 | I-PROMOTIONS, INC. |
9522 GRAVOIS RD. | ST. LOUIS | MO | 63123 |
| K021248 | IKEEPS, INC. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K140488 | MACA PLASTICS, INC. |
3455 CROSS ROAD | WINCHESTER | OH | 45697 |
| K142717 | Ni Hau Industrial Co., Ltd. |
No. 15, Alley 125, Lane 318, Section 2, An Ho Road | Tainan City | 70967 | |
| K071081 | NINGBO KAIDA RUBBER AND PLASTIC TECHNOLOGY CO., LT |
LANE 999, ZHONGSHAN NO. 2 ROAD | SHANGHAI | 200030 | |
| K130930 | NINGBO LISHUNDA ELECTRONICS CO., LTD. |
5 CAREY STREET | PENNINGTON | NJ | 08534 |
| K162869 | Ningbo Yinzhou Zonghai Artware Co., Ltd. |
Honglianchi, Guangsheng Village, Jishigang Town | Ningbo City | 315172 | |
| K143351 | Novabay Pharmaceuticals, Inc |
5980 Horton St., | Emeryville | CA | 94608 |
| K032309 | NOVELENS, INC. |
15825 SHADY GROVE ROAD | ROCKVILLE | MD | 20850 |
| K172925 | P L Overseas Limited |
Rm. A 4/F Alexandra Indl. Bldg. Blk.A | Cheung Sha Wan | ||
| K974635 | PARAGON VISION SCIENCES |
947 EAST IMPALA AVE. | MESA | AZ | 85204 |
| K993486 | PARAGON VISION SCIENCES |
947 EAST IMPALA AVE. | MESA | AZ | 85204 |
| K993487 | PARAGON VISION SCIENCES |
947 EAST IMPALA AVE. | MESA | AZ | 85204 |
| K030987 | PELICAN PRODUCTS |
611 EISENHAUER ST. | GRAND JUNCTION | CO | 81505 |
| K231123 | Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. |
EL-209, Shil Mahape Road Electronic Zone; | Navi Mumbai | 400710 | |
| K962512 | POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P. |
1400 N. GOODMAN ST. | ROCHESTER | NY | 14692 |
| K122700 | PROSBEN, INC. |
11 F., NO. 58, SEC. 3 | TAIPEI | 104 | |
| K120904 | RELIANCE DESIGN & MANUFACTURE CORP. |
611 WEST FIFTH STREET | AUSTIN | TX | 78701 |
| K093377 | RELIANCE DESIGN & MANUFACTURING CORP. |
3F, # 25 YI-6TH ROAD | KEELUNG | 20148 | |
| K121030 | SACKS HOLDINGS, INC. |
P.O. BOX 676211 | RANCHO SANTA FE | CA | 92067 |
| K052809 | SAUFLON PHARMACEUTICALS, LTD. |
49-53 YORK ST. | TWICKENHAM, MIDDLESEX | TW1-3LP | |
| K033656 | SAUFLON PHARMACEUTICALS, LTD. |
49-53 YORK ST. | TWICKENHAM, MIDDLESEX | TW1-3LP | |
| K130285 | THE LAGADO CORP. |
187 BALLARDVALE STREET | WILMINGTON | MA | 01887 |
| K131783 | VIOPTI LTD |
POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE | DUMBARTON | G82 3PW | |
| K090362 | VOGUESTRAP |
55 Northern Blvd | Great Neck | NY | 11021 |
| K130753 | WATCHDOG GROUP, LC |
7800 Forsyth Blvd. | Clayton | MO | 63105 |
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