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510(k) K162566

AIK Sterile Acupuncture Needles for Single Use by Changchun Aik Medical Devices Co., Ltd. — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2017
Date Received
September 14, 2016
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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  • K103061 — BIOMATE STERILE ACUPUNCTURE NEEDLE (June 20, 2011)
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  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)
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