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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 K962371
Device Name DERMTOME BLADE
Applicant
DSP WORLDWIDE
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
DSP WORLDWIDE
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number878.4820
Classification Product Code
GFD  
Date Received06/19/1996
Decision Date 08/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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