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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K113773
Device Name ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
Applicant
ST. JUDE MEDICAL
15900 Valley View Court
Sylmar,  CA  91342
Applicant Contact GEENA GEORGE
Correspondent
ST. JUDE MEDICAL
15900 Valley View Court
Sylmar,  CA  91342
Correspondent Contact GEENA GEORGE
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/22/2011
Decision Date 01/18/2012
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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