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FDA 510(k) Application Details - K180232
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K180232
Device Name
Electrode, Cutaneous
Applicant
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung-City 15084 KR
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Contact
Da Roo Ha
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
01/29/2018
Decision Date
04/03/2019
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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