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FDA 510(k) Application Details - K211753
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K211753
Device Name
Syringe, Antistick
Applicant
Jiangxi Hongda Medical Equipment Group Ltd.
No. 39 South Shengli Road
Nanchang 331700 CN
Other 510(k) Applications for this Company
Contact
Xiaohua Yang
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
MEG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/07/2021
Decision Date
10/14/2021
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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