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510(k) K151437

ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug by Atrium Medical Corporation — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2015
Date Received
May 29, 2015
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

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