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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handle, scalpel
510(k) Number K863951
Device Name P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
Applicant
PRECISION SURGICAL INDUSTRIES, INC.
2507 RTE. 22 W
SCOTCH PLAINS,  NJ  07076
Applicant Contact R. J BEDNER
Correspondent
PRECISION SURGICAL INDUSTRIES, INC.
2507 RTE. 22 W
SCOTCH PLAINS,  NJ  07076
Correspondent Contact R. J BEDNER
Regulation Number878.4800
Classification Product Code
GDZ  
Date Received10/10/1986
Decision Date 10/24/1986
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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