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FDA 510(k) Application Details - K221777
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K221777
Device Name
Syringe, Piston
Applicant
Weihai Shengjie Medical Technology Co., Ltd
No.58, Chuhe South Road
High-Tech Industrial District, Weihai
Weihai 264210 CN
Other 510(k) Applications for this Company
Contact
Huihui Wang
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/2022
Decision Date
10/06/2023
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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