The following data is part of a premarket notification filed by Germiphene Corp. with the FDA for Perlident.
Device ID | K894933 |
510k Number | K894933 |
Device Name: | PERLIDENT |
Classification | Agent, Polishing, Abrasive, Oral Cavity |
Applicant | GERMIPHENE CORP. P.O. BOX 1748 Brantford Ontario, CA N3t 5v7 |
Contact | Alan Schwartz |
Correspondent | Alan Schwartz GERMIPHENE CORP. P.O. BOX 1748 Brantford Ontario, CA N3t 5v7 |
Product Code | EJR |
CFR Regulation Number | 872.6030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-03 |
Decision Date | 1989-10-12 |