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510(k) K123479

PROGRIP LAPAROSCOPIC SELF-FIXATING MESH by Sofradim Production — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2012
Date Received
November 13, 2012
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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