The following data is part of a premarket notification filed by Hofa Llc. with the FDA for Breath Taker.
| Device ID | K971887 |
| 510k Number | K971887 |
| Device Name: | BREATH TAKER |
| Classification | Scraper, Tongue |
| Applicant | HOFA LLC. 180 EAST 2100 SOUTH Salt Lake City, UT 84115 |
| Contact | Zudhir Nadkarni |
| Correspondent | Zudhir Nadkarni HOFA LLC. 180 EAST 2100 SOUTH Salt Lake City, UT 84115 |
| Product Code | LCN |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-21 |
| Decision Date | 1997-06-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BREATH TAKER 75240508 2153581 Dead/Cancelled |
BOFA, LLC 1997-02-12 |