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FDA 510(k) Application Details - K163161
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K163161
Device Name
Syringe, Piston
Applicant
JiangXi HongDa Medical Equipment Group Ltd.
No. 39 South Shengli Road, Jinxian County
Nanchang 331700 CN
Other 510(k) Applications for this Company
Contact
Yang Xiaohua
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
11/10/2016
Decision Date
03/20/2017
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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