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510(k) K191028

KLS Martin Individual Patient Solutions by KLS-Martin L.P. — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2019
Date Received
April 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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