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FDA 510(k) Application Details - K213095
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K213095
Device Name
Endoscope Channel Accessory
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
More FDA Info for this Regulation Number
Classification Product Code
ODC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2021
Decision Date
01/12/2022
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
N
Expedited Review
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