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510(k) K121289

LTM-LABAROSCOPIC SURGICAL MESH by Lifecell Corp. — Product Code OXK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 3, 2012
Date Received: April 30, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Device Class: Class II
Regulation Number: 878.3300
Review Panel: SU
Submission Type

For reinforcement of soft tissue where weakness exists in abdominal wall defects.

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