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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K963006
Device Name SCION SAPHENOUS VEIN HARVESTING SYSTEM
Applicant
Scion International, Inc.
5200 Blue Lagoon Dr.,
Suite 890
Miami,  FL  33126
Applicant Contact FRANK GOLDFARB
Correspondent
Scion International, Inc.
5200 Blue Lagoon Dr.,
Suite 890
Miami,  FL  33126
Correspondent Contact FRANK GOLDFARB
Regulation Number878.4800
Classification Product Code
GAD  
Date Received08/02/1996
Decision Date 09/20/1996
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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