The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Cui Nasal Septum Button.
Device ID | K871200 |
510k Number | K871200 |
Device Name: | CUI NASAL SEPTUM BUTTON |
Classification | Button, Nasal Septal |
Applicant | COX-UPHUFF INTL. 1160 MARK AVE. Carpinteria, CA 93013 |
Contact | David J Schuessler |
Correspondent | David J Schuessler COX-UPHUFF INTL. 1160 MARK AVE. Carpinteria, CA 93013 |
Product Code | LFB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-25 |
Decision Date | 1987-04-15 |