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FDA 510(k) Application Details - K192773
Device Classification Name
More FDA Info for this Device
510(K) Number
K192773
Device Name
ALLIVE
Applicant
Nu Eyne Co., Ltd
#403, Seoul Biohub, 117-3 Hoegi-ro, Dongdaemun-gu
Seoul 02455 KR
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Contact
Dong Seong Lee
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PCC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2019
Decision Date
12/06/2019
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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