The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Flexible Hydroxylapatite/silicone Soft Chin Implan.
| Device ID | K925610 |
| 510k Number | K925610 |
| Device Name: | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN |
| Classification | Prosthesis, Chin, Internal |
| Applicant | MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Contact | Claude Wright |
| Correspondent | Claude Wright MICROTEK MEDICAL, INC. POST OFFICE BOX 2487 Columbus, MS 39704 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1994-11-18 |