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510(k) K061517

PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES by Prime Herbs Corporation — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2006
Date Received
June 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Acupuncture, Single Use
Device Class
Class II
Regulation Number
880.5580
Review Panel
HO
Submission Type

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