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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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Device Classification Name rigid sterilization container with software
De Novo Number DEN210004
Device Name Zuno Smart Sterilization Container
Requester
zuno medical, inc.
743 camden ave, suite b
campbell,  CA  95008
Contact allan mcnichol
Regulation Number880.6855
Classification Product Code
QJT  
Date Received02/16/2021
Decision Date 06/17/2022
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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