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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Razor, Surgical
510(k) Number K874370
Device Name SURGICAL PREP RAZOR
Applicant
Derma-Safe Co.
32 Juniper Rd.
Wayne,  NJ  07470
Applicant Contact WARREN J GROSJEAN
Correspondent
Derma-Safe Co.
32 Juniper Rd.
Wayne,  NJ  07470
Correspondent Contact WARREN J GROSJEAN
Regulation Number878.4800
Classification Product Code
LWK  
Date Received10/26/1987
Decision Date 11/13/1987
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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