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FDA 510(k) Application Details - K171722
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K171722
Device Name
Electrode, Cutaneous
Applicant
Shenzhen Konmed Technology Co., Ltd
703B, Haide building A, Nanxin Road, Nanshan
Shenzhen 518000 CN
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Contact
Tony Tony
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
06/12/2017
Decision Date
01/10/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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