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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 K040883
Device Name EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM
Applicant
ADVANCED STERILIZATION PRODUCTS
33 technology dr.
irvine,  CA  92618
Contact neelu medhekar
Regulation Number876.1500
Classification Product Code
FEB  
Date Received04/05/2004
Decision Date 03/15/2005
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
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