FDA 510(k) Application Details - DEN230011

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230011
Device Name	OcuCool
Applicant	RecensMedical, Inc. #507, #908, SK V1 Center 830 Dongtansunhwan-daero Hwaseong-si 18468 KR Other 510(k) Applications for this Company
Contact	Gun-Ho Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2023
Decision Date	09/30/2024
Decision	DENG -
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review