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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 K142873
Device Name OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
Applicant
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact Christine Lloyd
Correspondent
C.R. Bard, Inc.
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact Christine Lloyd
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/01/2014
Decision Date 03/12/2015
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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