OOLI-U(TONGUE SCRAPER)— 510(k) K970042

Substantially Equivalent

Telefax Intl.

FDA 510(k) clearance K970042 for OOLI-U(TONGUE SCRAPER), Substantially Equivalent on 1997-03-14. Applicant: Telefax Intl.. Device class: 1.

Clearance details

Applicant: Telefax Intl.
Product code: Code LCN
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1997-01-06
Decision date: 1997-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, 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.