FDA 510(k) Application Details - K141531

Device Classification Name Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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510(K) Number K141531
Device Name Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
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Contact BRYAN U STONE
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Regulation Number 876.5540

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Classification Product Code NIE
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Date Received 06/09/2014
Decision Date 06/01/2015
Decision SEKD - SUBST EQUIV - KIT WITH DRUGS
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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