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FDA 510(k) Application Details - K210059
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K210059
Device Name
Needle, Hypodermic, Single Lumen
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
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/11/2021
Decision Date
07/21/2021
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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