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510(k) K120728

PHASIX PLUG AND PATCH by C.R. Bard, Inc. — Product Code OWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2012
Date Received
March 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

For reinforcement of soft tissue where weakness exists during hernia repair.

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Other clearances for product code OWT

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  • K191773 — GORE BIO-A Tissue Reinforcement (July 31, 2019)
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  • K173143 — Phasix ST Mesh (April 25, 2018)
  • K163005 — TIGR Matrix Surgical Mesh (July 27, 2017)
  • K143380 — Phasix ST Mesh (June 5, 2015)
  • K101287 — TEPHAFLEX COMPOSITE MESH (August 30, 2010)
  • K033671 — GORE BIOABSORBABLE MESH (December 31, 2003)