Home / 510(k) Clearances / K171357

510(k) K171357

SurgiMend PRS Meshed, Revize-X by Integra Lifesciences Corporation (Owner of Tei Biosciences) — Product Code OXH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 7, 2017
Date Received: May 9, 2017
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.