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FDA 510(k) Application Details - K221368
Device Classification Name
Lancet, Blood
More FDA Info for this Device
510(K) Number
K221368
Device Name
Lancet, Blood
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
878.4800
More FDA Info for this Regulation Number
Classification Product Code
FMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/12/2022
Decision Date
06/09/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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