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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 K182998
Device Name Andorate Auxiliary Water Connector
Applicant
Smartdata Suzhou Co., Ltd.
4f, Block 7, 198#, Jinshan Rd.
Suzhou,  CN 215011
Applicant Contact Cindy Ye
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
OCX  
Date Received10/30/2018
Decision Date 04/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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