The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Cox Disposable Polypectomy Snares.
Device ID | K923671 |
510k Number | K923671 |
Device Name: | COX DISPOSABLE POLYPECTOMY SNARES |
Classification | Snare, Flexible |
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 | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-22 |
Decision Date | 1992-10-13 |