FDA 510(k) Application Details - K051316

Device Classification Name Catheter, Nephrostomy

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510(K) Number K051316
Device Name Catheter, Nephrostomy
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact JOHN C KNORPP
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Regulation Number 000.0000

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Classification Product Code LJE
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Date Received 05/20/2005
Decision Date 07/18/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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