IBC FLOPUMP WITH GBS COATING

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

GISH BIOMEDICAL, INC.

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

Pre-market Notification Details

Device IDK031300
510k NumberK031300
Device Name:IBC FLOPUMP WITH GBS COATING
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
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 CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-24
Decision Date2003-05-14
Summary:summary

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