The following data is part of a premarket notification filed by Block Drug Company, Inc. with the FDA for Duo Two Layer Denture Cleanser.
| Device ID | K791064 |
| 510k Number | K791064 |
| Device Name: | DUO TWO LAYER DENTURE CLEANSER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | BLOCK DRUG COMPANY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-11 |
| Decision Date | 1979-10-09 |