FDA 510(k) Application Details - K111756

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K111756
Device Name Colonoscope 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 STACY ABBATIELLO KLUESNER
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 06/22/2011
Decision Date 03/20/2012
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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