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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Absorbable, Abdominal Hernia
510(k) Number K173143
Device Name Phasix ST Mesh
Applicant
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact Tony John
Correspondent
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact Tony John
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
FTL   OOD   OWZ   OXC  
Date Received09/29/2017
Decision Date 04/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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