BREATH TAKER— 510(k) K971887

Substantially Equivalent

Hofa, LLC

FDA 510(k) clearance K971887 for BREATH TAKER, Substantially Equivalent on 1997-06-10. Applicant: Hofa, LLC. Device class: 1.

Clearance details

Applicant: Hofa, LLC
Product code: Code LCN
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1997-05-21
Decision date: 1997-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCN

K992270 — MIRACLEBREATH TONGUE CLEANER1999-09-23
K990344 — ORALGIENE TONGUE CLEANER1999-05-04
K983683 — UNIK TONGUE CLEANER1999-01-14
K983087 — BREATHTIQUE TONGUE SCRAPER1998-11-18
K981808 — BREATHAID TONGUE SCRAPER1998-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.