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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K092483
Device Name BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
Applicant
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact KEVIN STEVENS
Correspondent
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact KEVIN STEVENS
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/13/2009
Decision Date 12/18/2009
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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