Miromatrix Biological Mesh— 510(k) K160400

Name: FDA 510(k) clearance K160400
Creator: U.S. Food and Drug Administration
Published: 2016-06-08

Substantially Equivalent

Miromatrix Medical, Inc.

FDA 510(k) clearance K160400 for Miromatrix Biological Mesh, Substantially Equivalent on 2016-06-08. Applicant: Miromatrix Medical, Inc.. Device class: 2.

Clearance details

Applicant: Miromatrix Medical, Inc.
Product code: Code OXH
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2016-02-12
Decision date: 2016-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, 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.