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510(k) K063154

FACIAL RECONSTRUCTIVE MESH (FRM) by Evera Medical, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2007
Date Received
October 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Evera Medical, Inc.

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