FDA 510(k) Application Details - K070913

Device Classification Name Anoscope And Accessories

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510(K) Number K070913
Device Name Anoscope And Accessories
Applicant SAPIMED S.P.A.
1676 VILLAGE GREEN, SUITE A
CROFTON, MD 21114 US
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Contact E J SMITH
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Regulation Number 876.1500

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Classification Product Code FER
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Date Received 04/02/2007
Decision Date 08/10/2007
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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