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FDA 510(k) Application Details - K222514
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K222514
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
S.I.N. û Sistema de Implante Nacional S.A.
Avenida Vereador Abel Ferreira, 1100
Sπo Paulo 03340-000 BR
Other 510(k) Applications for this Company
Contact
Denise Domiciano
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
08/19/2022
Decision Date
10/27/2022
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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