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FDA 510(k) Application Details - K201293
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K201293
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
3rd & 4th Floor, No.2 Building, 366 Huiqing Road
Zhangjiang High-Tech Park
Shanghai 201201 CN
Other 510(k) Applications for this Company
Contact
Shuwen Fan
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FGB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2020
Decision Date
07/24/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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