FDA 510(k) Application Details - K050688

Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology

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510(K) Number K050688
Device Name Endoscopic Injection Needle, Gastroenterology-Urology
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact TERRI MORRIS
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Regulation Number 876.1500

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Classification Product Code FBK
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Date Received 03/17/2005
Decision Date 04/06/2005
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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