FDA 510(k) Application Details - DEN210004

Device Classification Name

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510(K) Number DEN210004
Device Name Zuno Smart Sterilization Container
Applicant Zuno Medical, Inc.
743 Camden Ave, Suite B
Campbell, CA 95008 US
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Contact Allan McNichol
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Regulation Number

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Classification Product Code QJT
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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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