FDA 510(k) Application Details - K142575

Device Classification Name Catheter, Straight

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510(K) Number K142575
Device Name Catheter, Straight
Applicant C.R. Bard, Inc.
8195 Industrial Blvd
Covington, GA 30014 US
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Contact Michele Davis
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Regulation Number 876.5130

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Classification Product Code EZD
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Date Received 09/12/2014
Decision Date 10/31/2014
Decision SESE - SUBST EQUIV
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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