The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for High Profile Chin Implant.
| Device ID | K911516 |
| 510k Number | K911516 |
| Device Name: | HIGH PROFILE CHIN IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Dvorah A Richman |
| Correspondent | Dvorah A Richman IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724ACS1 | K911516 | 000 |
| M724ACM1 | K911516 | 000 |
| M724ACL1 | K911516 | 000 |
| M724ACXL1 | K911516 | 000 |