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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 K021095
Device Name HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
Applicant
Wujiang City Hua Xin Medical Appliance Co., Ltd.
10 Westmont Rd.
Candler,  NC  28715
Applicant Contact LAURA J THORNE
Correspondent
Wujiang City Hua Xin Medical Appliance Co., Ltd.
10 Westmont Rd.
Candler,  NC  28715
Correspondent Contact LAURA J THORNE
Regulation Number880.5580
Classification Product Code
MQX  
Date Received04/04/2002
Decision Date 05/17/2002
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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