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510(k) K143386

Progrip Laparoscopic Self-Fixating Mesh by Sofradim Production — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2015
Date Received
November 26, 2014
Clearance Type
Special
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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