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FDA 510(k) Application Details - K130768
Device Classification Name
Stimulator, Electro-Acupuncture
More FDA Info for this Device
510(K) Number
K130768
Device Name
Stimulator, Electro-Acupuncture
Applicant
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
ROOM 1706, NO.128 SONGLE RD
SONGJIANG AREA
SHANGHAI 201600 CN
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Contact
DORIS DONG
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
BWK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2013
Decision Date
08/16/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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