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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 K120728
Device Name PHASIX PLUG AND PATCH
Applicant
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact SHERMA WINSTON
Correspondent
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact SHERMA WINSTON
Regulation Number878.3300
Classification Product Code
OWT  
Subsequent Product Code
OOD  
Date Received03/09/2012
Decision Date 10/22/2012
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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