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FDA 510(k) Application Details - K200479
Device Classification Name
Endoscopic Irrigation/Suction System
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510(K) Number
K200479
Device Name
Endoscopic Irrigation/Suction System
Applicant
GA Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin
Hong Kong CN
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Contact
Cindy Ye
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCX
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More FDA Info for this Product Code
Date Received
02/27/2020
Decision Date
05/15/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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