The following data is part of a premarket notification filed by Combe, Inc. with the FDA for Cfr Monograph.
| Device ID | K925259 |
| 510k Number | K925259 |
| Device Name: | CFR MONOGRAPH |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | COMBE, INC. 1101 WESTCHESTER AVE. White Plains, NY 10604 |
| Contact | Daniel R Johnson |
| Correspondent | Daniel R Johnson COMBE, INC. 1101 WESTCHESTER AVE. White Plains, NY 10604 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-19 |
| Decision Date | 1993-01-11 |