The following data is part of a premarket notification filed by Breathaid, Llc. with the FDA for Breathaid Tongue Scraper.
| Device ID | K981808 |
| 510k Number | K981808 |
| Device Name: | BREATHAID TONGUE SCRAPER |
| Classification | Scraper, Tongue |
| Applicant | BREATHAID, LLC. KEENAN BLDG., 3RD FLOOR 1330 LADY STREET COLUMBIA, SC 29211 |
| Contact | J. DOUGLAS NUNN, JR. |
| Correspondent | J. DOUGLAS NUNN, JR. BREATHAID, LLC. KEENAN BLDG., 3RD FLOOR 1330 LADY STREET COLUMBIA, SC 29211 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-08-11 |