FDA 510(k) Application Details - K033778

Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology

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510(K) Number K033778
Device Name Endoscopic Access Overtube, Gastroenterology-Urology
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON, GA 30014 US
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Contact FRAN HARRISON
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Regulation Number 876.1500

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Classification Product Code FED
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Date Received 12/04/2003
Decision Date 12/30/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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