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510(k) K200632

TCAT TKA Instrument Tray Set by THINK Surgical, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2020
Date Received
March 10, 2020
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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