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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 K082392
Device Name EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact JOSEPH ASCENZI, PH.D.
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact JOSEPH ASCENZI, PH.D.
Regulation Number876.1500
Classification Product Code
FEB  
Date Received08/19/2008
Decision Date 11/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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