THERMIQUE— 510(k) K022097

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K022097 for THERMIQUE, Substantially Equivalent on 2002-09-06. Applicant: Parkell, Inc.. Device class: 2.

Clearance details

Applicant: Parkell, Inc.
Product code: Code EAT
Device class: Class 2
Regulation: 21 CFR 872.1720
Advisory panel: Dental
Date received: 2002-06-27
Decision date: 2002-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, 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.