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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scalpel, One-Piece
510(k) Number K871894
Device Name KCK INDUSTRIES' SURGICAL INSTRUMENTS
Applicant
Kck Industries
4613 Rombers Pl.
Woodland Hills,  CA  91364
Applicant Contact BRUCE R SATHER
Correspondent
Kck Industries
4613 Rombers Pl.
Woodland Hills,  CA  91364
Correspondent Contact BRUCE R SATHER
Regulation Number878.4800
Classification Product Code
GDX  
Date Received05/01/1987
Decision Date 06/23/1987
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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