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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 K191287
Device Name OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
Applicant
Davol Inc., Subsidiary of C.R. Bard
100 Crossings Blvd.
Warwick,  RI  02886
Applicant Contact Angelica Hutchison
Correspondent
Davol Inc., Subsidiary of C.R. Bard
100 Crossings Blvd.
Warwick,  RI  02886
Correspondent Contact Angelica Hutchison
Regulation Number878.4750
Classification Product Code
GDW  
Date Received05/13/2019
Decision Date 07/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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