NORMATEC PCD— 510(k) K013436

Substantially Equivalent

Normatec, Inc.

FDA 510(k) clearance K013436 for NORMATEC PCD, Substantially Equivalent on 2001-12-21. Applicant: Normatec, Inc.. Device class: 2.

Clearance details

Applicant: Normatec, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2001-10-16
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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