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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K901231
Device Name RMI CARDIOPLEGIA DELIVERY KITS
Applicant
RESEARCH MEDICAL, INC.
1847 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
RESEARCH MEDICAL, INC.
1847 WEST 2300 SOUTH
SALT LAKE CITY,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/14/1990
Decision Date 06/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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