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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K892426
Device Name NO. 86500 - ENDOSCOPIC JET WASHER
Applicant
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Applicant Contact PAUL BERNARD
Correspondent
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Correspondent Contact PAUL BERNARD
Regulation Number876.1500
Classification Product Code
OCX  
Date Received04/10/1989
Decision Date 06/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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