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FDA 510(k) Application Details - K211890
Device Classification Name
Container, Sharps
More FDA Info for this Device
510(K) Number
K211890
Device Name
Container, Sharps
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
880.5570
More FDA Info for this Regulation Number
Classification Product Code
MMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/2021
Decision Date
11/17/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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