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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dermatome
510(k) Number K945594
Device Name DECA DERMATOME (MICROMOTOR SYSTEM)
Applicant
Depuy Intl., Ltd.
St Anthony'S Rd.
Leeds, Ls 11 8dt
West Yorkshire,  GB LS11 8DT
Applicant Contact IAN WATERHOUSE
Correspondent
Depuy Intl., Ltd.
St Anthony'S Rd.
Leeds, Ls 11 8dt
West Yorkshire,  GB LS11 8DT
Correspondent Contact IAN WATERHOUSE
Regulation Number878.4820
Classification Product Code
GFD  
Date Received11/14/1994
Decision Date 06/05/1995
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
Predetermined Change
Control Plan Authorized		 No
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