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510(k) K092240

ACUPUNCTURE NEEDLES by Haenglim Seowon Medical Co. — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2010
Date Received
July 23, 2009
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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