THORASTAT ATR-XXXX

Defoamer, Cardiopulmonary Bypass

GISH BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Thorastat Atr-xxxx.

Pre-market Notification Details

Device IDK870792
510k NumberK870792
Device Name:THORASTAT ATR-XXXX
ClassificationDefoamer, Cardiopulmonary Bypass
Applicant GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana,  CA  92705
ContactJeanne Pierson
CorrespondentJeanne Pierson
GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana,  CA  92705
Product CodeDTP  
CFR Regulation Number870.4230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-26
Decision Date1987-04-28

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