FDA 510(k) Application Details - K063446

Device Classification Name Kit, Repair, Catheter, Hemodialysis

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510(K) Number K063446
Device Name Kit, Repair, Catheter, Hemodialysis
Applicant C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY, UT 84116 US
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Contact PEGGY KEIFFER
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Regulation Number 876.5540

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Classification Product Code NFK
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Date Received 11/15/2006
Decision Date 12/15/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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