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 |