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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessories, cleaning, for endoscope
510(k) Number K061899
Device Name EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
Original Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine,  CA  92618
Original Contact joseph m ascenzi
Regulation Number876.1500
Classification Product Code
FEB  
Date Received07/03/2006
Decision Date 10/26/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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