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510(k) K103061

BIOMATE STERILE ACUPUNCTURE NEEDLE by Biomate Medical Devices Technology Co., Ltd. — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2011
Date Received
October 18, 2010
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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