The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implantech Conform Binder Submalar Implant.
| Device ID | K973502 |
| 510k Number | K973502 |
| Device Name: | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT |
| Classification | Implant, Malar |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1997-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724CBSMXL1 | K973502 | 000 |
| M724CBSMM1 | K973502 | 000 |
| M724CBSML1 | K973502 | 000 |
| M724CBSMS1 | K973502 | 000 |