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510(k) K222005

S.I.N. Instrument Kits by S.I.N. - Sistema DE Implante Nacional S.A. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2022
Date Received
July 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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