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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K924503
Device Name PERSONNA SAFETY SCALPEL
Applicant
American Safety Razor Co.
P.O. Box 500
Staunton,  VA  24401
Applicant Contact JOHN T SIMPSON
Correspondent
American Safety Razor Co.
P.O. Box 500
Staunton,  VA  24401
Correspondent Contact JOHN T SIMPSON
Regulation Number878.4800
Classification Product Code
MDM  
Date Received09/04/1992
Decision Date 02/05/1993
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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