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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, ear, internal
510(k) Number K863939
Device Name POREX(TM) EAR PROSTHESIS
Applicant
POREX MEDICAL
500 BOHANNON RD.
FAIRBURN,  GA  30213
Applicant Contact HOWARD A MERCER,PHD
Correspondent
POREX MEDICAL
500 BOHANNON RD.
FAIRBURN,  GA  30213
Correspondent Contact HOWARD A MERCER,PHD
Regulation Number878.3590
Classification Product Code
FZD  
Date Received10/10/1986
Decision Date 10/24/1986
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
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