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 |