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 |