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 |