FDA 510(k) Application Details - K011825

Device Classification Name Anoscope And Accessories

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510(K) Number K011825
Device Name Anoscope And Accessories
Applicant SIGHTLINE TECHNOLOGIES LTD.
ADVANCED TECHNOLOGY CENTER
MATAM, HAIFA 31905 IL
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Contact SIMCHA EDELL
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Regulation Number 876.1500

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Classification Product Code FER
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Date Received 06/11/2001
Decision Date 07/11/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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