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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K915869
Device Name RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
Applicant
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact RD HUBBERT
Correspondent
Research Medical, Inc.
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact RD HUBBERT
Regulation Number870.4450
Classification Product Code
MJN  
Date Received12/31/1991
Decision Date 12/08/1992
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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