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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 K200495
Device Name Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
Applicant
Ga Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu St., Shatin
Hong Kong,  CN
Applicant Contact Cindy Ye
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number876.1500
Classification Product Code
ODC  
Date Received02/28/2020
Decision Date 06/24/2020
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
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