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510(k) K121216

STR GRAFT by Soft Tissue Regeneration, Inc. — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2012
Date Received
April 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

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