FDA 510(k) Application Details - K070508

Device Classification Name Catheter, Retention Type, Balloon

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510(K) Number K070508
Device Name Catheter, Retention Type, Balloon
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact MICHELLE GUDITH
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Regulation Number 876.5130

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Classification Product Code EZL
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Date Received 02/22/2007
Decision Date 03/09/2007
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 Y
Expedited Review



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