Comfort Cover— 510(k) K161920

Substantially Equivalent

Precision Dynamics Corporation

FDA 510(k) clearance K161920 for Comfort Cover, Substantially Equivalent on 2016-07-15. Applicant: Precision Dynamics Corporation. Device class: 2.

Clearance details

Applicant: Precision Dynamics Corporation
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2016-07-13
Decision date: 2016-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, 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.