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510(k) K151347

MIS Spine Frame Instrument Case by Thompson Surgical Instruments — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2015
Date Received
May 20, 2015
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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