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FDA 510(k) Application Details - K210946
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K210946
Device Name
Instrument, Biopsy
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang
District
Hangzhou City 311121 CN
Other 510(k) Applications for this Company
Contact
Zearou Yang
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2021
Decision Date
08/12/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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