The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Cox Disposable Cytology Brushes.
Device ID | K914466 |
510k Number | K914466 |
Device Name: | COX DISPOSABLE CYTOLOGY BRUSHES |
Classification | Endoscopic Cytology Brush |
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 | FDX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-07 |
Decision Date | 1991-10-25 |