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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 K061517
Device Name PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES
Applicant
Prime Herbs Corporation
754 San Aleso Ave.
Sunnyvale,  CA  94085
Applicant Contact GENEVIEVE HSIA
Correspondent
Prime Herbs Corporation
754 San Aleso Ave.
Sunnyvale,  CA  94085
Correspondent Contact GENEVIEVE HSIA
Regulation Number880.5580
Classification Product Code
MQX  
Date Received06/01/2006
Decision Date 11/22/2006
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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