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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name marker, radiographic, implantable
510(k) Number K082278
Device Name MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
Applicant
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Applicant Contact CAROL HUBBARD
Correspondent
ETHICON ENDO-SUGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Correspondent Contact CAROL HUBBARD
Regulation Number878.4300
Classification Product Code
NEU  
Subsequent Product Code
FZP  
Date Received08/11/2008
Decision Date 12/16/2008
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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