The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Aquapulse Auxiliary Water Connector.
|Device Name:||AquaPulse Auxiliary Water Connector|
|Classification||Endoscopic Irrigation/suction System|
|Applicant||GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN|
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708
|CFR Regulation Number||876.1500 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||Yes|