FDA 510(k) Applications for Medical Device:
Elastomer, Silicone, For Scar Management
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K053481 | ADVANCED BIO-TECHNOLOGIES, INC. |
P.O. BOX 3515 | REDMOND | WA | 98073-3515 |
| K002488 | ADVANCED BIO-TECHNOLOGIES, INC. |
53 NEEDHAM DR. | CRANAGE, CHESHIRE | CW4 8FB | |
| K991630 | ADVANCED MEDICAL SOLUTIONS GROUP PLC |
ROAD THREE, | WINSFORD, CHESHIRE | CW7 3PD | |
| K010245 | ADVANCED MEDICAL SOLUTIONS LTD. |
ROAD THREE | WINSFORD, CHESHIRE | CW7 3PD | |
| K023678 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
5871 LONE PINE PLACE | PASO ROBLES | CA | 93446 |
| K982051 | ALLIED BIOMEDICAL CORP. |
3850 RAMADA DR., SUITE C-2 | PASO ROBLES | CA | 93446 |
| K981353 | AVOCET POLYMER TECHNOLOGIES, INC. |
2305 SPRING BRANCH RD. | HUNTSVILLE | AL | 35801 |
| K083718 | BEAU RX SOLUTIONS, LLC. |
PO BOX 51-1117 | MELBOURNE BEACH | FL | 32951 |
| K024057 | BEIERSDORF, INC. |
700 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20005-5929 |
| K023136 | BIO MED SCIENCES, INC. |
1111 W. HAMILTON ST. | ALLENTOWN | PA | 18101 |
| K002109 | BIO MED SCIENCES, INC. |
1111 HAMILTON ST. | ALLENTOWN | PA | 18101 |
| K982036 | BIO MED SCIENCES, INC. |
101 TECHNOLOGY DR. | BETHLEHEM | PA | 18015 |
| K003948 | BIODERMIS CORP. |
3078 EAST SUNSET RD. SUITE #1 | LAS VEGAS | NV | 89120 |
| K991604 | BIODERMIS CORP. |
3078 EAST SUNSET RD. SUITE #1 | LAS VEGAS | NV | 89120 |
| K992146 | BIODERMIS CORP. |
3078 EAST SUNSET RD. SUITE #1 | LAS VEGAS | NV | 89120 |
| K001608 | BLAINE LABS, INC. |
9624 SOUTH JOHN ST. | SANTA FE SPRINGS | CA | 90679 |
| K963128 | BRENNEN MEDICAL, INC. |
1290 HAMMOND RD. | ST. PAUL | MN | 55110 |
| K984213 | CAPITAL MARKETING TECHNOLOGIES, INC. |
3630 SOUTH I-35, SUITE A | WACO | TX | 76706 |
| K991478 | CAPITAL MARKETING TECHNOLOGIES, INC. |
3630 SOUTH I-35, SUITE A | WACO | TX | 76706 |
| K111733 | CORELEADER BIOTECH CO., LTD. |
19F NO. 100, SEC 1 | NEW TAIPEI, TAIWAN | 22102 | |
| K971482 | DEGANIA SILICONE, LTD. |
DEGANIA BET | EMEK HAYARDEN | 15130 | |
| K010675 | GOTTFRIED MEDICAL, INC. |
4105 W. ALEXIS RD. | TOLEDO | OH | 43623 |
| K040307 | HANSON MEDICAL, INC. |
P.O. BOX 1296 | KINGSTON | WA | 98346 |
| K973572 | HANSON MEDICAL, INC. |
P.O. BOX 1160 | KINGSTON | WA | 98346 |
| K012419 | IMPLANTECH ASSOCIATES, INC. |
2064 EASTMAN AVE., UNIT 101 | VENTURA | CA | 93003 |
| K013732 | IMPLANTECH ASSOCIATES, INC. |
2064 EASTMAN AVE., UNIT 101 | VENTURA | CA | 93003 |
| K964846 | IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW | WASHINGTON | DC | 20006 |
| K974143 | KMC INTL. CO. |
1260 LINCOLN AVE., #1200 | PASADENA | CA | 91103 |
| K991312 | LIBRARY MEDICAL, INC. |
60 TERENCE DR. | PITTSBURGH | PA | 15236 |
| K980563 | LIFE MEDICAL SCIENCES, INC. |
310 MADISON AVE, 22ND FLOOR | NEW YORK | NY | 10017 |
| K981387 | MEDICAL SCIENTIFIC, INC. |
125 JOHN HANCOCK RD. | TAUNTON | MA | 02780 |
| K971916 | MEDICAL Z, S.A. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K003979 | MEDTRADE PRODUCTS LTD. |
ELECTRA HOUSE | CREWE, CHESHIRE | CW1 6GL | |
| K014036 | MEDTRADE PRODUCTS LTD. |
ELECTRA HOUSE | CREWE, CHESHIRE CW1 6GL | CW1 6GL | |
| K962013 | MENTOR CORP. |
5425 HOLLISTER AVE. | SANTA BARBARA | CA | 93111 |
| K984029 | NAGOR LTD. |
PO BOX 21 DOUGLAS | BRITISH ISLES | ||
| K974172 | NAGOR LTD. |
PO BOX 21 DOUGLAS | BRITISH ISLES | ||
| K112131 | NEODYNE BIOSCIENCES, INC. |
127 Independence Drive | Menlo Park | CA | 94025 |
| K041704 | NEWMEDICAL TECHNOLOGY, INC. |
3324 COMMERCIAL AVENUE | NORTHBROOK | IL | 60062 |
| K991970 | PILLAR SURGICAL |
PO BOX 8141 | LA JOLLA | CA | 92038 |
| K972597 | PMT CORP. |
1500 PARK RD. | CHANHASSEN | MN | 55317 |
| K974380 | REJUVENESS PHARAMCEUTICALS, INC. |
100 SARATOGA VILLAGE BLVD. | BALLSTON SPA | NY | 12020 |
| K960254 | ROFIL MEDICAL USA, INC. |
26856 OAK HOLLOW RD. | LAGUNA HILLS | CA | 92653-2036 |
| K974354 | SCA MOLNLYCKE |
500 BALDWIN TOWER | EDDYSTONE | PA | 19022 |
| K984115 | SCAREASE, INC. |
PO BOX 500356 | POWAY | CA | 92150 |
| K955664 | SILIPOS, INC. |
366 MADISON AVE. | NEW YORK | NY | 10017 |
| K991957 | SMITH & NEPHEW, INC. |
11775 STARKEY RD. | LARGO | FL | 33773-4727 |
| K991968 | SMITH & NEPHEW, INC. |
11775 STARKEY RD. | LARGO | FL | 33773-4727 |
| K971468 | SPECIALTY SYSTEMS, INC. |
1312 VERACRUZ LN. | WESTERN | FL | 33327 |
| K970702 | SPECTRUM DESIGNS, INC. |
5921 C. MATTHEWS ST. | GOLETA | CA | 93117 |
| K992522 | SPECTRUM DESIGNS, INC. |
6387 B ROSE LN. | CARPINETERIA | CA | 93013 |
| K981902 | SPENCO MEDICAL CORP. |
6301 IMPERIAL DR. | WACO | TX | 76712 |
| K971009 | TARGET HEALTH, INC. |
310 MADISON AVE. | NEW YORK | NY | 10017 |
| K973271 | TARGET HEALTH, INC. |
310 MADISON AVE. | NEW YORK | NY | 10017 |
| K961410 | THE S. F. GROUP, INC. |
304 WEST MAIN ST. | GRAND JUNCTION | CO | 81505 |
| K990651 | UNITED HOSPITAL TECHNOLOGIES, INC. |
10320 USA TODAY WAY | MIRAMAR | FL | 33025 |
| K024160 | WARNER-LAMBERT CO. |
201 TABOR RD. | MORRIS PLAINS | NJ | 07950 |
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