The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Curvilinear Silicone Chin Implant.
Device ID | K902941 |
510k Number | K902941 |
Device Name: | CURVILINEAR SILICONE CHIN IMPLANT |
Classification | Prosthesis, Chin, Internal |
Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
Contact | Edward M Basile,esq |
Correspondent | Edward M Basile,esq 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 | 1990-07-03 |
Decision Date | 1990-08-02 |