MEDOS HILITE RESERVOIR, MODEL: 4030

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 Medos Hilite Reservoir, Model: 4030.

Pre-market Notification Details

Device IDK083131
510k NumberK083131
Device Name:MEDOS HILITE RESERVOIR, MODEL: 4030
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita,  CA  92688
ContactJanet Peets
CorrespondentJanet Peets
GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita,  CA  92688
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-23
Decision Date2009-07-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.