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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K033700
Device Name MAMMOTOME EX HAND HELD SYSTEM
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Applicant Contact CAROL SPRINKLE
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Correspondent Contact CAROL SPRINKLE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/25/2003
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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