The following data is part of a premarket notification filed by Enfresh Products Llc. with the FDA for Enfresh Tongue Brush.
| Device ID | K973424 |
| 510k Number | K973424 |
| Device Name: | ENFRESH TONGUE BRUSH |
| Classification | Scraper, Tongue |
| Applicant | ENFRESH PRODUCTS LLC. 555 13TH STREET, NW. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein, Esg |
| Correspondent | Howard M Holstein, Esg ENFRESH PRODUCTS LLC. 555 13TH STREET, NW. Washington, DC 20004 -1109 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1997-12-09 |
| Summary: | summary |