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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 K001718
Device Name MILLENNIA ACUPUNCTURE NEEDLE
Applicant
United Pacific Co., Ltd.
219 S. Raymond Ave.
Alhambra,  CA  91801
Applicant Contact DANIEL YE HUA
Correspondent
United Pacific Co., Ltd.
219 S. Raymond Ave.
Alhambra,  CA  91801
Correspondent Contact DANIEL YE HUA
Regulation Number880.5580
Classification Product Code
MQX  
Date Received06/05/2000
Decision Date 06/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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