The following data is part of a premarket notification filed by Telefax Intl. with the FDA for Ooli-u(tongue Scraper).
| Device ID | K970042 |
| 510k Number | K970042 |
| Device Name: | OOLI-U(TONGUE SCRAPER) |
| Classification | Scraper, Tongue |
| Applicant | TELEFAX INTL. 23704-5 EL TORO RD. SUITE 527 Lake Forest, CA 92630 |
| Contact | Upen Shah |
| Correspondent | Upen Shah TELEFAX INTL. 23704-5 EL TORO RD. SUITE 527 Lake Forest, CA 92630 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-03-14 |
| Summary: | summary |