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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 K231602
Device Name Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
Applicant
GA Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin
Hong Kong,  HK
Applicant Contact Cindy Ye
Correspondent
GA Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin
Hong Kong,  HK
Correspondent Contact Wing Yu Lam
Regulation Number876.1500
Classification Product Code
OCX  
Date Received06/01/2023
Decision Date 08/01/2023
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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