FDA 510(k) Application Details - K024033

Device Classification Name Duodenoscope And Accessories, Flexible/Rigid

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510(K) Number K024033
Device Name Duodenoscope And Accessories, Flexible/Rigid
Applicant OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
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Contact LAURA STORMS-TYLER
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Regulation Number 876.1500

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Classification Product Code FDT
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Date Received 12/06/2002
Decision Date 12/20/2002
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 Y
Expedited Review



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