FDA 510(k) Application Details - K052930

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K052930
Device Name Colonoscope And Accessories, Flexible/Rigid
Applicant NEOGUIDE SYSTEMS, INC.
104 COOPER COURT
LOS GATOS, CA 95032 US
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Contact MICHAEL A DANIEL
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 10/19/2005
Decision Date 01/31/2006
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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