The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Combined Malar Implant.
| Device ID | K910655 |
| 510k Number | K910655 |
| Device Name: | COMBINED MALAR IMPLANT |
| Classification | Implant, Malar |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Dvorah Richman |
| Correspondent | Dvorah Richman 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 | 1991-02-14 |
| Decision Date | 1991-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724CSMXL1 | K910655 | 000 |
| M724CSMS1 | K910655 | 000 |
| M724CSMM1 | K910655 | 000 |
| M724CSML1 | K910655 | 000 |
| M724CCSMXS1 | K910655 | 000 |
| M724CCSMXL1 | K910655 | 000 |
| M724CCSMS1 | K910655 | 000 |
| M724CCSMM1 | K910655 | 000 |
| M724CCSML1 | K910655 | 000 |