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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
Applicant
CUSTOM ULTRASONICS
144 RAILROAD DR.
IVYLAND,  PA  18974
Applicant Contact FRANK J WEBER
Correspondent
CUSTOM ULTRASONICS
144 RAILROAD DR.
IVYLAND,  PA  18974
Correspondent Contact FRANK J WEBER
Regulation Number876.1500
Classification Product Code
FEB  
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
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