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510(k) K150341

Miromatrix Biological Mesh RS by Miromatrix Medical, Inc. — Product Code OXH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 12, 2015
Date Received: February 11, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class: Class II
Regulation Number: 878.3300
Review Panel: SU
Submission Type

For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.