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510(k) K151104

OTELO LL by Spineart — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2016
Date Received
April 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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