FDA 510(k) Application Details - K122812

Device Classification Name Stimulator, Electro-Acupuncture

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510(K) Number K122812
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
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Regulation Number 000.0000

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Classification Product Code BWK
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Date Received 09/13/2012
Decision Date 04/11/2013
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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