The following data is part of a premarket notification filed by Unik Products, Inc. with the FDA for Unik Tongue Cleaner.
| Device ID | K983683 |
| 510k Number | K983683 |
| Device Name: | UNIK TONGUE CLEANER |
| Classification | Scraper, Tongue |
| Applicant | UNIK PRODUCTS, INC. SALIBURY & CAMBRIA LLP 42 DELAWARE AVENUE, SUITE 300 Buffalo, NY 14202 |
| Contact | Harry E Werner |
| Correspondent | Harry E Werner UNIK PRODUCTS, INC. SALIBURY & CAMBRIA LLP 42 DELAWARE AVENUE, SUITE 300 Buffalo, NY 14202 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-20 |
| Decision Date | 1999-01-14 |
| Summary: | summary |