The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Cox Diaposable Polypectomy Snare.
| Device ID | K912254 |
| 510k Number | K912254 |
| Device Name: | COX DIAPOSABLE POLYPECTOMY SNARE |
| 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 | 1991-05-21 |
| Decision Date | 1991-07-26 |