MACROPORE CARDIO-WRAP (TS)— 510(k) K031785

Name: FDA 510(k) clearance K031785
Creator: U.S. Food and Drug Administration
Published: 2003-09-04

Substantially Equivalent

Macropore Biosurgery, Inc.

FDA 510(k) clearance K031785 for MACROPORE CARDIO-WRAP (TS), Substantially Equivalent on 2003-09-04. Applicant: Macropore Biosurgery, Inc.. Device class: 2.

Clearance details

Applicant: Macropore Biosurgery, Inc.
Product code: Code OMH
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2003-06-10
Decision date: 2003-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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