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510(k) K163028

Medline ReNewal Reprocessed Stryker External Fixation Devices by Surgical Instrument Service and Savings, Inc. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2016
Date Received
October 31, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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