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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K140437
Device Name SU-POR SURGICAL IMPLANT
Applicant
Poriferous, LLC
535 Pine Rd., Suite 206
Newnan,  GA  30263
Applicant Contact AARON NOBLE
Correspondent
Poriferous, LLC
535 Pine Rd., Suite 206
Newnan,  GA  30263
Correspondent Contact AARON NOBLE
Regulation Number878.3500
Classification Product Code
KKY  
Subsequent Product Code
FWP  
Date Received02/21/2014
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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