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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chisel (osteotome)
510(k) Number K872947
Device Name POREX QUALITY PLASTIC SURGERY INSTRUMENTS
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 Number878.4820
Classification Product Code
KDG  
Date Received07/28/1987
Decision Date 08/21/1987
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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