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510(k) K182507

Tigon Medical Tissue Anchors by Tigon Medical — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2019
Date Received
September 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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