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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 K061430
Device Name SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
Applicant
Custom Ultrasonics
144 Railroad Dr.
Ivyland,  PA  18974
Applicant Contact LAWRENCE F MUSCARELLA
Correspondent
Custom Ultrasonics
144 Railroad Dr.
Ivyland,  PA  18974
Correspondent Contact LAWRENCE F MUSCARELLA
Regulation Number876.1500
Classification Product Code
FEB  
Date Received05/23/2006
Decision Date 01/12/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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