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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 K122172
Model SYSTEM 83 PLUS
Device Name SYSTEM 83 PLUS
Original Applicant
CUSTOM ULTRASONICS
144 railroad dr.
ivyland,  PA  18974
Original Contact frank j weber
Regulation Number876.1500
Classification Product Code
FEB  
Date Received08/01/2012
Decision Date 01/25/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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