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FDA 510(k) Application Details - K243749
Device Classification Name
Media, Electroconductive
More FDA Info for this Device
510(K) Number
K243749
Device Name
Media, Electroconductive
Applicant
Shenzhen Ulike Smart Electronics Co., Ltd.
810, Building 1, Xunmei Science and Technology Plaza
No. 8 Keyuan Road, Science Park Community
Shenzhen CN
Other 510(k) Applications for this Company
Contact
Yang Blue
Other 510(k) Applications for this Contact
Regulation Number
882.1275
More FDA Info for this Regulation Number
Classification Product Code
GYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2024
Decision Date
04/08/2025
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
FDA Source Information for K243749
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