Home / 510(k) Clearances / K150903

510(k) K150903

EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural by Maanshan Bond Medical Instruments Co., Ltd. — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2015
Date Received
April 3, 2015
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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