The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Cox Disposable Endoscope Cleaning Brush(cb-x2).
Device ID | K924655 |
510k Number | K924655 |
Device Name: | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) |
Classification | Accessories, Cleaning, For Endoscope |
Applicant | COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
Contact | Lanita Cox |
Correspondent | Lanita Cox COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
Product Code | FEB |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-15 |
Decision Date | 1992-12-15 |