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510(k) K142760

Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles by K.S. Choi Corporation — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2015
Date Received
September 25, 2014
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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