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 Other 510(k) Applications for this Company
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