GUTTAFLOW— 510(k) K032662

Substantially Equivalent

Coltene/Whaledent GmbH & Co. KG

FDA 510(k) clearance K032662 for GUTTAFLOW, Substantially Equivalent on 2003-11-03. Applicant: Coltene/Whaledent GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent GmbH & Co. KG
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2003-08-28
Decision date: 2003-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuyahoga Falls, OH, US

Download summary PDF View on FDA.gov ↗

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