FDA 510(k) Application Details - K070330

Device Classification Name Colonoscope And Accessories, Flexible/Rigid

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510(K) Number K070330
Device Name Colonoscope And Accessories, Flexible/Rigid
Applicant AVANTIS MEDICAL SYSTEMS, INC.
263 SANTA ANA CT.
SUNNYVALE, CA 94085 US
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Contact SCOTT RUTHERFORD
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Regulation Number 876.1500

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Classification Product Code FDF
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Date Received 02/05/2007
Decision Date 04/24/2007
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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