D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS— 510(k) K112525

Name: FDA 510(k) clearance K112525
Creator: U.S. Food and Drug Administration
Published: 2011-09-29

Substantially Equivalent

Parexel International

FDA 510(k) clearance K112525 for D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS, Substantially Equivalent on 2011-09-29. Applicant: Parexel International. Device class: 2.

Clearance details

Applicant: Parexel International
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2011-08-31
Decision date: 2011-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, 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.