The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Surgiform Anatomical Malar.
| Device ID | K964443 |
| 510k Number | K964443 |
| Device Name: | SURGIFORM ANATOMICAL MALAR |
| Classification | Implant, Malar |
| Applicant | SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland, OH 44103 |
| Contact | Richard T Nock |
| Correspondent | Richard T Nock SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland, OH 44103 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1996-12-20 |