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FDA 510(k) Applications for Medical Device Product Code "OWT"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K203267
Biorez, Inc.
The BioBrace Implant
04/30/2021
K143380
C. R. Bard Inc
Phasix ST Mesh
06/05/2015
K173143
C. R. Bard Inc
Phasix ST Mesh
04/25/2018
K120728
C.R. BARD INC
PHASIX PLUG AND PATCH
10/22/2012
K190185
C.R. Bard, Inc.
Phasix ST Mesh with Open Positioning System
06/12/2019
K163005
NOVUS SCIENTIFIC AB
TIGR Matrix Surgical Mesh
07/27/2017
K191749
Novus Scientific AB
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
03/26/2020
K101287
TEPHA, INC.
TEPHAFLEX COMPOSITE MESH
08/30/2010
K033671
W. L. GORE & ASSOCIATES, INC.
GORE BIOABSORBABLE MESH
12/31/2003
K191773
W.L. Gore & Associates, Inc.
GORE BIO-A Tissue Reinforcement
07/31/2019
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