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510(k) K133046

OMNIPORE CUSTOMIZED SURGICAL IMPLANTS by Matrix Surgical Holdings, LLC/Matrix Surgical USA — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2014
Date Received
September 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

Other clearances by Matrix Surgical Holdings, LLC/Matrix Surgical USA

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  • K103010 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (October 26, 2010)
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