RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Aortic Root/coronary Sinus Monit./infusion Set.

Pre-market Notification Details

Device IDK892377
510k NumberK892377
Device Name:RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
ContactMichael N Kelly
CorrespondentMichael N Kelly
RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-06
Decision Date1989-12-07

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