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510(k) K133889

PREMIUM by Cousin Biotech Sas — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2014
Date Received
December 20, 2013
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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