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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscope and/or accessories
510(k) Number K983017
Device Name MODIFICATION TO SYSTEM 83 PLUS
Original Applicant
CUSTOM ULTRASONICS
144 railroad dr.
ivyland,  PA  18974
Original Contact frank j weber
Regulation Number876.1500
Classification Product Code
KOG  
Date Received08/28/1998
Decision Date 09/22/1998
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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