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FDA 510(k) Application Details - K141349
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K141349
Device Name
Syringe, Antistick
Applicant
GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD
Mazha Industrial Area, Liusha Town
BAIYUN DISTRICT OF GUANGZHOU CITY
Puning City 518034 CN
Other 510(k) Applications for this Company
Contact
SALON CHEN
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
05/22/2014
Decision Date
04/10/2015
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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