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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope channel accessory
510(k) Number K191231
Device Name Andorate Auxiliary Water Connector, Andorate Valves Set
Applicant
Smartdata Suzhou Co., Ltd
4F, Block 7, 198#, Jinshan Rd
Suzhou,  CN 215011
Applicant Contact Cindy Ye
Correspondent
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number876.1500
Classification Product Code
ODC  
Subsequent Product Code
OCX  
Date Received05/08/2019
Decision Date 06/07/2019
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
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