FDA 510(k) Application Details - K133687

Device Classification Name Anoscope And Accessories

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510(K) Number K133687
Device Name Anoscope And Accessories
Applicant THD SPA
VIA A.ALTOBELLI BONETTI, 3/A
IMOLA, BO 40026 IT
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Contact GUIDO BONAPACE
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Regulation Number 876.1500

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Classification Product Code FER
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Date Received 12/02/2013
Decision Date 12/11/2013
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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