FDA 510(k) Application Details - K032688

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K032688
Device Name Colonoscope And Accessories, Flexible/Rigid
Applicant SIGHTLINE TECHNOLOGIES LTD.
MATAM - BLDG. 20
HAIFA 31905 IL
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Contact SHARON GOLDFARB-ALBAK
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 08/29/2003
Decision Date 03/05/2004
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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