The following data is part of a premarket notification filed by Oralgiene Usa, Inc. with the FDA for Oralgiene Tongue Cleaner.
| Device ID | K990344 |
| 510k Number | K990344 |
| Device Name: | ORALGIENE TONGUE CLEANER |
| Classification | Scraper, Tongue |
| Applicant | ORALGIENE USA, INC. 8460 HIGUERA ST. Culver City, CA 90232 |
| Contact | Bill Muckleroy |
| Correspondent | Bill Muckleroy ORALGIENE USA, INC. 8460 HIGUERA ST. Culver City, CA 90232 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-04 |
| Decision Date | 1999-05-04 |
| Summary: | summary |