COOL TEMP NATURAL— 510(k) K041098

Substantially Equivalent

Coltene AG

FDA 510(k) clearance K041098 for COOL TEMP NATURAL, Substantially Equivalent on 2004-05-13. Applicant: Coltene AG. Device class: 2.

Clearance details

Applicant: Coltene AG
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2004-04-27
Decision date: 2004-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.