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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K012350
Device Name MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
Applicant
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Applicant Contact HOWARD MERCER
Correspondent
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Correspondent Contact HOWARD MERCER
Regulation Number878.3550
Classification Product Code
FWP  
Date Received07/25/2001
Decision Date 03/14/2002
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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