The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Basics Endoscopy System.
Device ID | K940911 |
510k Number | K940911 |
Device Name: | BASICS ENDOSCOPY SYSTEM |
Classification | Forceps, Biopsy, Electric |
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 | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-25 |
Decision Date | 1994-05-16 |