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 |