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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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De Novo Number DEN230011
Device Name OcuCool
Requester
recensmedical, inc.
#507, #908, sk v1 center, 830 dongtansunhwan-daero
hwaseong-si,  KR 18468
Contact gun-ho kim
Classification Product Code
QZQ
Date Received02/16/2023
Decision Date 09/30/2024
Decision granted (DENG)
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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