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510(k) K231604

Instrument Case by Cochlear Americas — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
June 1, 2023
Clearance Type
Special
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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