SCION SAPHENOUS VEIN HARVESTING SYSTEM

Retractor

SCION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Scion International, Inc. with the FDA for Scion Saphenous Vein Harvesting System.

Pre-market Notification Details

Device IDK963006
510k NumberK963006
Device Name:SCION SAPHENOUS VEIN HARVESTING SYSTEM
ClassificationRetractor
Applicant SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami,  FL  33126
ContactFrank Goldfarb
CorrespondentFrank Goldfarb
SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami,  FL  33126
Product CodeGAD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-02
Decision Date1996-09-20

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