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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 K923689
Device Name SURGISTAR BLADES
Applicant
Surgistar, Inc.
P.O. Box 2722
Vista,  CA  92085
Applicant Contact JONATHAN WOODWARD
Correspondent
Surgistar, Inc.
P.O. Box 2722
Vista,  CA  92085
Correspondent Contact JONATHAN WOODWARD
Regulation Number878.4800
Classification Product Code
GDX  
Date Received07/24/1992
Decision Date 09/09/1992
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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