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FDA 510(k) Application Details - K200942
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K200942
Device Name
Electrode, Cutaneous
Applicant
Well-Life Healthcare Limited
6F., No, 168, Lide St., Jhonghe District
New Taipei City 235 TW
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Contact
Jenny Hsieh
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
04/08/2020
Decision Date
06/01/2021
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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