FDA 510(k) Applications for Medical Device:
Implant, Malar
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K021419 | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. |
3545 AIRWAY DR. | RENO | NV | 89511 |
| K971479 | ALLIED BIOMEDICAL CORP. |
3850 RAMADA DR., SUITE C-2 | PASO ROBLES | CA | 93446 |
| K960362 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K960354 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K973574 | HANSON MEDICAL, INC. |
P.O. BOX 1160 | KINGSTON | WA | 98346 |
| K002886 | IMPLANTECH ASSOCIATES, INC. |
2064 EASTMAN AVE., UNIT 101 | VENTURA | CA | 93003 |
| K973502 | IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW | WASHINGTON | DC | 20006 |
| K962261 | IMPLANTECH ASSOCIATES, INC. |
1730 PENNSYLVANIA AVENUE, NW | WASHINGTON | DC | 20006 |
| K961511 | LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. | CHASKA | MN | 55318 |
| K970400 | ORTHOFIX, INC. |
250 EAST ARAPAHO RD. | RICHARDSON | TX | 75081 |
| K992240 | PILLAR SURGICAL, INC. |
P.O. BOX 8141 | LA JOLLA | CA | 92038 |
| K961080 | RAND SCIENTIFIC CORP. |
4135 NORTHGATE BLVD., SUITE 9 | SACRAMENTO | CA | 95834 |
| K982763 | SEARE BIOMEDICAL CORP. |
3190 CHULA VISTA CIRCLE | SALT LAKE CITY | UT | 84121 |
| K981835 | SILIMED, LLC. |
P.O BOX 4341 | CROFTON | MD | 21114 |
| K980140 | SPECTRUM DESIGNS, INC. |
5921 C. MATTHEWS ST. | GOLETA | CA | 93117 |
| K980139 | SPECTRUM DESIGNS, INC. |
5921 C. MATTHEWS ST. | GOLETA | CA | 93117 |
| K980141 | SPECTRUM DESIGNS, INC. |
5921 C. MATTHEWS ST. | GOLETA | CA | 93117 |
| K964443 | SURGICAL TECHNOLOGY LABORATORIES, INC. |
1588 EAST 40TH ST. | CLEVELAND | OH | 44103 |
| K983756 | SURGICAL TECHNOLOGY LABORATORIES, INC. |
1588 EAST 40TH ST. | CLEVELAND | OH | 44103 |
| K961210 | W.L. GORE & ASSOCIATES,INC |
3750 WEST KILTIE LN. | FLAGSTAFF | AZ | 86001 |
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