FDA 510(k) Application Details - K001241

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K001241
Device Name Colonoscope And Accessories, Flexible/Rigid
Applicant THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE, NY 11747 US
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Contact LAURA STORMS-TYLER
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 04/18/2000
Decision Date 05/09/2000
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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