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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 K111323
Device Name SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
Applicant
SYNTHES INC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact ALAN T HALEY
Correspondent
SYNTHES INC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact ALAN T HALEY
Regulation Number878.3500
Classification Product Code
KKY  
Date Received05/11/2011
Decision Date 11/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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