The following data is part of a premarket notification filed by U.s. Dentek Corp. with the FDA for Tongue Scrapper.
| Device ID | K961574 |
| 510k Number | K961574 |
| Device Name: | TONGUE SCRAPPER |
| Classification | Scraper, Tongue |
| Applicant | U.S. DENTEK CORP. 1320 INDUSTRIAL AVE. Petaluma, CA 94952 |
| Contact | John Jansheki |
| Correspondent | John Jansheki U.S. DENTEK CORP. 1320 INDUSTRIAL AVE. Petaluma, CA 94952 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-23 |
| Decision Date | 1996-06-10 |