GORE BIO-A WOUND MATRIX— 510(k) K132397

Name: FDA 510(k) clearance K132397
Creator: U.S. Food and Drug Administration
Published: 2014-05-07

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K132397 for GORE BIO-A WOUND MATRIX, Substantially Equivalent on 2014-05-07. Applicant: W. L. Gore & Associates, Inc.. Device class: Unclassified.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code QSZ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2013-08-01
Decision date: 2014-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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.