AquaPulse Auxiliary Water Connector

Endoscopic Irrigation/suction System

GA Health Company Limited

The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Aquapulse Auxiliary Water Connector.

Pre-market Notification Details

Device IDK200479
510k NumberK200479
Device Name:AquaPulse Auxiliary Water Connector
ClassificationEndoscopic Irrigation/suction System
Applicant GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong,  CN
ContactCindy Ye
CorrespondentRafael Aguila
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum,  FL  33155 -3708
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-02-27
Decision Date2020-05-15

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