FDA 510(k) Application Details - K063632

Device Classification Name Catheter, Nephrostomy

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510(K) Number K063632
Device Name Catheter, Nephrostomy
Applicant C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON, GA 30014-6421 US
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Contact TERRI MORRIS
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Regulation Number 000.0000

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Classification Product Code LJE
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Date Received 12/06/2006
Decision Date 01/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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