Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6— 510(k) K161067

Name: FDA 510(k) clearance K161067
Creator: U.S. Food and Drug Administration
Published: 2016-09-15

Substantially Equivalent

Engineered Tissue Solutions, LLC

FDA 510(k) clearance K161067 for Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6, Substantially Equivalent on 2016-09-15. Applicant: Engineered Tissue Solutions, LLC. Device class: Unclassified.

Clearance details

Applicant: Engineered Tissue Solutions, LLC
Product code: Code QSZ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2016-04-15
Decision date: 2016-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rolla, MO, 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.