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FDA 510(k) Application Details - K192568
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K192568
Device Name
Electrode, Cutaneous
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd
NO.35 Baiqiao Rd., Ehu Town, Xishan District,
Wuxi 214116 CN
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Contact
Caihong Sun
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/2019
Decision Date
02/03/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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