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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 K162120
Device Name Scope-Assist Flushing Sink
Applicant
Custom Ultrasonics Inc.
144 Railroad Drive
Ivyland,  PA  18974
Applicant Contact Elizabeth Lazaro
Correspondent
Custom Ultrasonics Inc.
144 Railroad Drive
Ivyland,  PA  18974
Correspondent Contact Elizabeth Lazaro
Regulation Number876.1500
Classification Product Code
FEB  
Date Received08/01/2016
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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