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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 K232118
Device Name ANDORATE® Valve Kit
Applicant
Ga Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu St., Shatin
Hong Kong,  CN
Applicant Contact Cindy Ye
Correspondent
Ga Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu St., Shatin
Hong Kong,  CN
Correspondent Contact Wing Yu Lam
Regulation Number876.1500
Classification Product Code
ODC  
Subsequent Product Code
OCX  
Date Received07/17/2023
Decision Date 10/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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