The following data is part of a premarket notification filed by Combe, Inc. with the FDA for Otc Denture Cleanser.
Device ID | K942203 |
510k Number | K942203 |
Device Name: | OTC DENTURE CLEANSER |
Classification | Cleanser, Denture, Over The Counter |
Applicant | COMBE, INC. 1101 WESTCHESTER AVE. White Plains, NY 10604 |
Contact | Stephen C Pennisi |
Correspondent | Stephen C Pennisi 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 | 1994-05-05 |
Decision Date | 1994-08-10 |