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 |