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510(k) K140437

SU-POR SURGICAL IMPLANT by Poriferous, LLC — Product Code KKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2014
Date Received
February 21, 2014
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 Poriferous, LLC

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