Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing With Luer 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 Vacutore Air/water Bottle Tubing, Vacutore Co2 Tubing With Luer Connector.

Pre-market Notification Details

Device IDK200388
510k NumberK200388
Device Name:Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing With Luer 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 Received2020-02-18
Decision Date2020-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14897106954978 K200388 000
14897106950123 K200388 000
14897106950147 K200388 000
04897106950164 K200388 000
14897106950185 K200388 000
14897106950192 K200388 000
14897106950208 K200388 000
14897106953797 K200388 000
14897106954954 K200388 000
14897106950086 K200388 000

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