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510(k) K140734

NEXTGEN ALTIUS OCT SYSTEM by Ebi, LLC — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2014
Date Received
March 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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