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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 K891576
Device Name FEM-FLEX FEMORAL ACCESS CANNULATION SET
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 Received03/20/1989
Decision Date 10/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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