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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 K922489
Device Name MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
Applicant
POREX TECHNOLOGIES CORP.
500 BOHANNON RD.
FAIRBURN,  GA  30213
Applicant Contact HOWARD A MERCER
Correspondent
POREX TECHNOLOGIES CORP.
500 BOHANNON RD.
FAIRBURN,  GA  30213
Correspondent Contact HOWARD A MERCER
Regulation Number878.3550
Classification Product Code
FWP  
Date Received05/27/1992
Decision Date 09/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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