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FDA 510(k) Application Details - K162566
Device Classification Name
Needle, Acupuncture, Single Use
More FDA Info for this Device
510(K) Number
K162566
Device Name
Needle, Acupuncture, Single Use
Applicant
CHANGCHUN AIK MEDICAL DEVICES CO., LTD
NO. 25, KAREN INDUSTRIAL PARK,
JIUTAI ECONOMIC DEVELOPMENT ZONE
CHANGCHUN 130507 CN
Other 510(k) Applications for this Company
Contact
XINGWANG LI
Other 510(k) Applications for this Contact
Regulation Number
880.5580
More FDA Info for this Regulation Number
Classification Product Code
MQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2016
Decision Date
05/11/2017
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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