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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K920936
Device Name RMI EXTERNAL CORONARY ARTERY OCCLUDER
Applicant
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact RD HIBBERT
Correspondent
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact RD HIBBERT
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/28/1992
Decision Date 12/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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