V-BAG WITH GBS COATING

Reservoir, Blood, Cardiopulmonary Bypass

GISH BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for V-bag With Gbs Coating.

Pre-market Notification Details

Device IDK050195
510k NumberK050195
Device Name:V-BAG WITH GBS COATING
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston,  TX  77071
ContactJ. Harvey Knauss
CorrespondentJ. Harvey Knauss
GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston,  TX  77071
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-01-27
Decision Date2005-03-17
Summary:summary

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