The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Surgiform Augmentation Material (s.f.a.m.).
| Device ID | K021889 |
| 510k Number | K021889 |
| Device Name: | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland, OH 44103 |
| Contact | Cameron J Fordyce |
| Correspondent | Cameron J Fordyce SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland, OH 44103 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2002-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085198807990 | K021889 | 000 |
| 00850987007451 | K021889 | 000 |
| 00850987007444 | K021889 | 000 |
| 00850987007437 | K021889 | 000 |
| 00850987007420 | K021889 | 000 |
| 00850987007413 | K021889 | 000 |
| 00850987007406 | K021889 | 000 |
| 00850987007390 | K021889 | 000 |
| 00850987007383 | K021889 | 000 |
| 00850987007376 | K021889 | 000 |
| 00850987007369 | K021889 | 000 |
| 00850987007352 | K021889 | 000 |
| 00850987007345 | K021889 | 000 |
| 00850987007338 | K021889 | 000 |
| 00850987007321 | K021889 | 000 |
| 00850987007314 | K021889 | 000 |
| 00851988007990 | K021889 | 000 |
| 00854804007051 | K021889 | 000 |
| 00850987007468 | K021889 | 000 |
| 00850987007475 | K021889 | 000 |
| 00854804007037 | K021889 | 000 |
| 00854804007020 | K021889 | 000 |
| 00854804007013 | K021889 | 000 |
| 00854804007006 | K021889 | 000 |
| 00850987007604 | K021889 | 000 |
| 00850987007598 | K021889 | 000 |
| 00850987007581 | K021889 | 000 |
| 00850987007574 | K021889 | 000 |
| 00850987007567 | K021889 | 000 |
| 00850987007550 | K021889 | 000 |
| 00850987007543 | K021889 | 000 |
| 00850987007536 | K021889 | 000 |
| 00850987007529 | K021889 | 000 |
| 00850987007512 | K021889 | 000 |
| 00850987007505 | K021889 | 000 |
| 00850987007499 | K021889 | 000 |
| 00850987007482 | K021889 | 000 |
| 00854804007259 | K021889 | 000 |