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FDA 510(k) Applications Submitted by GA Health Company Limited
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230280
02/01/2023
ANDORATE« Suction Valve and ANDORATE« Biopsy Valve
GA Health Company Limited
K200388
02/18/2020
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
GA Health Company Limited
K200479
02/27/2020
AquaPulse Auxiliary Water Connector
GA Health Company Limited
K200481
02/27/2020
Andorate Biopsy Valve, Andorate Biopsy Irrigator
GA Health Company Limited
K200495
02/28/2020
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
GA Health Company Limited
K230932
04/03/2023
ANDORATE« Valve Kit
GA Health Company Limited
K231602
06/01/2023
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
GA Health Company Limited
K202560
09/04/2020
AquaPulse Irrigation Tubing
GA Health Company Limited
K213095
09/24/2021
andorate Suction Valve, andorate Air/Water Valve
GA Health Company Limited
K202838
09/25/2020
Andorate Universal Endoscope Tip Guard
GA Health Company Limited
K223171
10/11/2022
AquaPulse« Irrigation Tubing
GA Health Company Limited
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