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FDA 510(k) Application Details - K190700
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K190700
Device Name
Electrode, Cutaneous
Applicant
Shenzhen Bestpad Technology Development Co., Ltd
A16A17 Dong Jing Run Factory A301, Fourth Industrial Zone
Shenzhen 518105 CN
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Contact
Junwei Xu
Other 510(k) Applications for this Contact
Regulation Number
882.1320
More FDA Info for this Regulation Number
Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
03/18/2019
Decision Date
06/14/2019
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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