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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Film
510(k) Number K142818
Device Name Phasix Mesh
Applicant
C. R. Bard
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact Steve Keenan
Correspondent
C. R. Bard
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact Steve Keenan
Regulation Number878.3300
Classification Product Code
OOD  
Date Received09/29/2014
Decision Date 03/31/2015
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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