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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 K061430
Device Name SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
Applicant
CUSTOM ULTRASONICS
144 railroad dr.
ivyland,  PA  18974
Contact lawrence f muscarella
Regulation Number876.1500
Classification Product Code
FEB  
Date Received05/23/2006
Decision Date 01/12/2007
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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