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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
Device Name SYSTEM 83 PLUS
Original Applicant
144 railroad dr.
ivyland,  PA  18974
Original Contact frank j weber
Regulation Number876.1500
Classification Product Code
Date Received07/23/2012
Decision Date 01/25/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls