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FDA 510(k) Application Details - K221310
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K221310
Device Name
Endoscopic Irrigation/Suction System
Applicant
Changzhou Endoclean Medical Device Co., Ltd.
West Side of 4th Floor, Building E2, No.9 Changyang Road
Changzhou 213149 CN
Other 510(k) Applications for this Company
Contact
Wang Qi
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2022
Decision Date
10/07/2022
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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