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510(k) K172978

SurgeoBite by Surgovations, LLC — Product Code JXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2017
Date Received
September 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Bite
Device Class
Class II
Regulation Number
882.5070
Review Panel
NE
Submission Type

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