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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 K052731
Device Name KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
Applicant
Daxin LI
2600 Mission St.
Suite 100
San Marino,  CA  91108
Applicant Contact YINGCHAO XIAO
Correspondent
Daxin LI
2600 Mission St.
Suite 100
San Marino,  CA  91108
Correspondent Contact YINGCHAO XIAO
Regulation Number880.5580
Classification Product Code
MQX  
Date Received09/29/2005
Decision Date 02/01/2006
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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