TORAY VASCULAR PROSTHESIS

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

TORAY INDUSTRIES (AMERICA), INC.

The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toray Vascular Prosthesis.

Pre-market Notification Details

Device IDK884083
510k NumberK884083
Device Name:TORAY VASCULAR PROSTHESIS
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant TORAY INDUSTRIES (AMERICA), INC. 9223 ILONA LN. Houston,  TX  77025
ContactLisa S Jones
CorrespondentLisa S Jones
TORAY INDUSTRIES (AMERICA), INC. 9223 ILONA LN. Houston,  TX  77025
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-27
Decision Date1989-01-12

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