The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Nasal Dorsal Series.
| Device ID | K983755 |
| 510k Number | K983755 |
| Device Name: | NASAL DORSAL SERIES |
| Classification | Prosthesis, Nose, Internal |
| 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 | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-22 |
| Decision Date | 1998-11-20 |