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FDA 510(k) Application Details - K202616
Device Classification Name
Endoscopic Irrigation/Suction System
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510(K) Number
K202616
Device Name
Endoscopic Irrigation/Suction System
Applicant
Finemedix Co., Ltd.
60, Maeyeo-ro, Dong-gu
Daegu 41065 KR
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Contact
Seok-Jun Ma
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
09/09/2020
Decision Date
02/19/2021
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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