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510(k) K111392

WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) by Woojeon Company — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2011
Date Received
May 18, 2011
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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