The following data is part of a premarket notification filed by Stellar Labs, Inc. with the FDA for Miraclebreath Tongue Cleaner.
| Device ID | K992270 |
| 510k Number | K992270 |
| Device Name: | MIRACLEBREATH TONGUE CLEANER |
| Classification | Scraper, Tongue |
| Applicant | STELLAR LABS, INC. 6637 SUPERIOR AVENUE, SUITE D Sarasota, FL 34231 |
| Contact | Harlan Pomeroy Iii |
| Correspondent | Harlan Pomeroy Iii STELLAR LABS, INC. 6637 SUPERIOR AVENUE, SUITE D Sarasota, FL 34231 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 1999-09-23 |
| Summary: | summary |