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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 K961927
Device Name RMI HEMOCONCENTRACTOR TUBING SET
Applicant
RESEARCH MEDICAL, INC.
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Applicant Contact RD HIBBERT
Correspondent
RESEARCH MEDICAL, INC.
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Correspondent Contact RD HIBBERT
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/17/1996
Decision Date 08/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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