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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 K190185
Device Name Phasix ST Mesh with Open Positioning System
C.R. Bard, Inc.
100 Crossings Boulevard
Warwick,  RI  02886
Applicant Contact Shirin Mate
C.R. Bard, Inc.
100 Crossings Boulevard
Warwick,  RI  02886
Correspondent Contact Shirin Mate
Regulation Number878.3300
Classification Product Code
Subsequent Product Codes
Date Received02/01/2019
Decision Date 06/12/2019
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