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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 K170278
Device Name OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
Applicant
C.R. BARD INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact KATHERINE EARLE
Correspondent
C.R. BARD INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact KATHERINE EARLE
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/30/2017
Decision Date 05/31/2017
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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