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510(k) K160400

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 8, 2016
Date Received: February 12, 2016
Clearance Type: Special
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.