NormaTec PCD-T and PCD-B— 510(k) K161346

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K161346 for NormaTec PCD-T and PCD-B, Substantially Equivalent on 2016-06-15. Applicant: NormaTec Industries, LP.

Clearance details

Applicant: NormaTec Industries, LP
Product code: Code JOW
Advisory panel: Cardiovascular
Date received: 2016-05-16
Decision date: 2016-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

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