The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Modular Biopsy Forcep.
Device ID | K946360 |
510k Number | K946360 |
Device Name: | MODULAR BIOPSY FORCEP |
Classification | Forceps, Biopsy, Non-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 | FCL |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-30 |
Decision Date | 1995-03-06 |