FDA 510(k) Application Details - K113120

Device Classification Name Choledochoscope And Accessories, Flexible/Rigid

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510(K) Number K113120
Device Name Choledochoscope And Accessories, Flexible/Rigid
Applicant OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact SHERI MUSGNUNG
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Regulation Number 876.1500

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Classification Product Code FBN
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Date Received 10/21/2011
Decision Date 09/25/2012
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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