The following data is part of a premarket notification filed by Perrigo Co. with the FDA for Effervescent Denture Cleanser.
| Device ID | K880068 |
| 510k Number | K880068 |
| Device Name: | EFFERVESCENT DENTURE CLEANSER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | PERRIGO CO. 117 WATER ST. Allegan, MI 49010 |
| Contact | Rick Leber |
| Correspondent | Rick Leber PERRIGO CO. 117 WATER ST. Allegan, MI 49010 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-11 |
| Decision Date | 1988-03-07 |