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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
Model 1190600, 1190601, 1190602, 1190603
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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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