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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
Original Applicant
C.R. BARD INC
100 crossings boulevard
warwick,  RI  02886
Original 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
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