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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 K173590
Device Name System 83 Plus Washer/Disinfector
Applicant
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland,  PA  18974
Applicant Contact Mario P. Infanti
Correspondent
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland,  PA  18974
Correspondent Contact Mario P. Infanti
Regulation Number876.1500
Classification Product Code
FEB  
Date Received11/21/2017
Decision Date 03/30/2020
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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