The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Anatomical Malar Implant.
| Device ID | K901662 |
| 510k Number | K901662 |
| Device Name: | ANATOMICAL MALAR IMPLANT |
| Classification | Implant, Malar |
| 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 | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-10 |
| Decision Date | 1990-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724TMSXL71 | K901662 | 000 |
| M724CTMSS41 | K901662 | 000 |
| M724TMSXL41 | K901662 | 000 |
| M724TMSXL51 | K901662 | 000 |
| M724CTMSM41 | K901662 | 000 |
| M724CTMSXL41 | K901662 | 000 |
| M724TMSL31 | K901662 | 000 |
| M724TMSL41 | K901662 | 000 |
| M724TMSL51 | K901662 | 000 |
| M724TMSL61 | K901662 | 000 |
| M724TMSM31 | K901662 | 000 |
| M724TMSM41 | K901662 | 000 |
| M724TMSM51 | K901662 | 000 |
| M724TMSS31 | K901662 | 000 |
| M724TMSS41 | K901662 | 000 |
| M724TMSXL61 | K901662 | 000 |
| M724CTMSL41 | K901662 | 000 |