The following data is part of a premarket notification filed by Bonyf Ag with the FDA for Medical Interporous.
Device ID | K051342 |
510k Number | K051342 |
Device Name: | MEDICAL INTERPOROUS |
Classification | Cleanser, Denture, Over The Counter |
Applicant | BONYF AG 67 MAIN STREET Silver Creek, NY 14136 |
Contact | Donna Marie Hartnett |
Correspondent | Donna Marie Hartnett BONYF AG 67 MAIN STREET Silver Creek, NY 14136 |
Product Code | EFT |
CFR Regulation Number | 872.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-23 |
Decision Date | 2006-06-02 |