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 |