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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 K965256
Device Name DMS-1000C DERMOABRADER
Applicant
MATTIOLI ENGINEERING, SRL
VIALE MACHIAVELLI, 2/A
FLORENCE,  IT 50125
Applicant Contact GIAN FRANCO BERNABEI
Correspondent
MATTIOLI ENGINEERING, SRL
VIALE MACHIAVELLI, 2/A
FLORENCE,  IT 50125
Correspondent Contact GIAN FRANCO BERNABEI
Regulation Number878.4820
Classification Product Code
GFD  
Date Received08/16/1996
Decision Date 12/09/1996
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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