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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Acupuncture, Single Use
510(k) Number K162566
Device Name AIK Sterile Acupuncture Needles for Single Use
Applicant
Changchun Aik Medical Devices Co., Ltd.
# 25, Karen Industrial Park,
Jiutai Economic Development Zone
Changchun,  CN 130507
Applicant Contact XINGWANG LI
Correspondent
Changchun Aik Medical Devices Co., Ltd.
# 25, Karen Industrial Park,
Jiutai Economic Development Zone
Changchun,  CN 130507
Correspondent Contact XINGWANG LI
Regulation Number880.5580
Classification Product Code
MQX  
Date Received09/14/2016
Decision Date 05/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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