VASCUCOMP— 510(k) K103247

Substantially Equivalent

Thermotek, Inc.

FDA 510(k) clearance K103247 for VASCUCOMP, Substantially Equivalent on 2010-12-10. Applicant: Thermotek, Inc.. Device class: 2.

Clearance details

Applicant: Thermotek, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2010-11-03
Decision date: 2010-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flower Mound, TX, 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.