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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K892377
Device Name RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
Applicant
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received04/06/1989
Decision Date 12/07/1989
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
Recalls CDRH Recalls
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