The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Surgiform Anatomical Malar.
| Device ID | K983756 |
| 510k Number | K983756 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1998-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851988007815 | K983756 | 000 |
| 00850987007628 | K983756 | 000 |
| 00850987007635 | K983756 | 000 |
| 00850987007642 | K983756 | 000 |
| 00851988007334 | K983756 | 000 |
| 00851988007341 | K983756 | 000 |
| 00851988007358 | K983756 | 000 |
| 00851988007365 | K983756 | 000 |
| 00851988007723 | K983756 | 000 |
| 00851988007730 | K983756 | 000 |
| 00851988007747 | K983756 | 000 |
| 00851988007754 | K983756 | 000 |
| 00851988007761 | K983756 | 000 |
| 00851988007778 | K983756 | 000 |
| 00851988007785 | K983756 | 000 |
| 00851988007792 | K983756 | 000 |
| 00851988007808 | K983756 | 000 |
| 00850987007611 | K983756 | 000 |