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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 K143380
Device Name Phasix ST Mesh
Applicant
C.R. Bard, Inc.
100 Crossing Blvd.
Warwick,  RI  02886
Applicant Contact Tony John
Correspondent
C.R. Bard, Inc.
100 Crossing Blvd.
Warwick,  RI  02886
Correspondent Contact Tony John
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Codes
FTL   OOD  
Date Received11/25/2014
Decision Date 06/05/2015
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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