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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 K945931
Device Name RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE
Applicant
Research Industries Corp.
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact H IBBERT
Correspondent
Research Industries Corp.
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact H IBBERT
Regulation Number870.4290
Classification Product Code
DTL  
Date Received12/05/1994
Decision Date 03/03/1995
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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