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FDA 510(k) Application Details - DEN210004
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN210004
Device Name
Zuno Smart Sterilization Container
Applicant
Zuno Medical, Inc.
743 Camden Ave, Suite B
Campbell, CA 95008 US
Other 510(k) Applications for this Company
Contact
Allan McNichol
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/16/2021
Decision Date
06/17/2022
Decision
DENG -
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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