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FDA 510(k) Application Details - K181374
Device Classification Name
More FDA Info for this Device
510(K) Number
K181374
Device Name
NRFit Syringe
Applicant
Jiangsu Caina Medical Co., Ltd
No. 23, Huanxi Road, Zhutang Town
Jiangyin 214421 CN
Other 510(k) Applications for this Company
Contact
Jun Lu
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/24/2018
Decision Date
12/14/2018
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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