The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Ucb.
Device ID | K950689 |
510k Number | K950689 |
Device Name: | UCB |
Classification | Accessories, Cleaning Brushes, For Endoscope |
Applicant | COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
Contact | L Anita |
Correspondent | L Anita COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
Product Code | MNL |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-14 |
Decision Date | 1995-03-06 |