RMI EXTERNAL CORONARY ARTERY OCCLUDER

Clamp, Vascular

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi External Coronary Artery Occluder.

Pre-market Notification Details

Device IDK920936
510k NumberK920936
Device Name:RMI EXTERNAL CORONARY ARTERY OCCLUDER
ClassificationClamp, Vascular
Applicant RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale,  UT  84047
ContactRd Hibbert
CorrespondentRd Hibbert
RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale,  UT  84047
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-28
Decision Date1992-12-18

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