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510(k) K133469

ACUMED SUTURE ANCHOR SYSTEM by Acumed, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2014
Date Received
November 12, 2013
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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