HYDROFIX SURGICAL SHEET— 510(k) K100905

Substantially Equivalent

Mimedx Group, Inc.

FDA 510(k) clearance K100905 for HYDROFIX SURGICAL SHEET, Substantially Equivalent on 2010-06-02. Applicant: Mimedx Group, Inc.. Device class: 2.

Clearance details

Applicant: Mimedx Group, Inc.
Product code: Code OMR
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2010-04-01
Decision date: 2010-06-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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