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FDA 510(k) Application Details - K222328
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K222328
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
SteriCUBE, LLC
2701 Beach Boulevard South
Gulfport, FL 33707 US
Other 510(k) Applications for this Company
Contact
Michele Mauzerall
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/2022
Decision Date
09/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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