RMI CARDIOPLEGIA DELIVERY SETS

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 Cardioplegia Delivery Sets.

Pre-market Notification Details

Device IDK892368
510k NumberK892368
Device Name:RMI CARDIOPLEGIA DELIVERY SETS
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

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