CARDIOTOMY RESERVOIR BRS-XXX SERIES &

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 Cardiotomy Reservoir Brs-xxx Series &.

Pre-market Notification Details

Device IDK843888
510k NumberK843888
Device Name:CARDIOTOMY RESERVOIR BRS-XXX SERIES &
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana,  CA  92705
ContactWendell V Ebling
CorrespondentWendell V Ebling
GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana,  CA  92705
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-02
Decision Date1985-02-14

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