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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Cleaner, Automated, Endoscope
510(k) Number K983017
Device Name MODIFICATION TO 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
NVE  
Date Received08/28/1998
Decision Date 09/22/1998
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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