FDA 510(k) Application Details - K993840

Device Classification Name Dilator, Catheter, Ureteral

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510(K) Number K993840
Device Name Dilator, Catheter, Ureteral
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact ANGELA L BUNN
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Regulation Number 876.5470

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Classification Product Code EZN
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Date Received 11/12/1999
Decision Date 01/31/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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