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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blade, scalpel
510(k) Number K873142
Device Name PERSONNA DISPOSABLE SCALPEL
Applicant
AMERICAN SAFETY RAZOR CO.
P.O. BOX 500
STAUNTON,  VA  24401
Applicant Contact JANE O SAWYER
Correspondent
AMERICAN SAFETY RAZOR CO.
P.O. BOX 500
STAUNTON,  VA  24401
Correspondent Contact JANE O SAWYER
Regulation Number878.4800
Classification Product Code
GES  
Date Received08/10/1987
Decision Date 09/04/1987
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
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