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510(k) K181268

PROLENE (Polypropylene) 3D Patch by Ethicon, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2018
Date Received
May 14, 2018
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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