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510(k) K130817

LTN - LAPAROSCOPIC SURGICAL MESH by Lifecell Corp. — Product Code OXK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 17, 2013
Date Received: March 25, 2013
Clearance Type: Special
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.

Other clearances by Lifecell Corp.

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K082103 — LTM WOUND DRESSING (October 8, 2008)
K080353 — LTM-T SURGICAL MESH (April 3, 2008)
K071986 — LTM-RC SURGICAL MESH (October 19, 2007)
K070560 — LRTM SURGICAL MESH (June 11, 2007)
K061208 — LIFECELL DURAL SUBSTITUTE MATRIX (January 3, 2007)
K052735 — ALLOCRAFT DBM (December 28, 2005)