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510(k) K203492

Instrument tray, for semi-rigid ureteroscope by Olympus Winter & Ibe GmbH — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2021
Date Received
November 19, 2020
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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