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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K160854
Device Name MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
Applicant
Biomet Manafacturing Corp.
56 East Bell Drive
PO Box 587
Warsaw,  IN  46581
Applicant Contact Adam Cargill
Correspondent
Biomet Manafacturing Corp.
56 East Bell Drive
PO Box 587
Warsaw,  IN  46581
Correspondent Contact Jared Cooper
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/28/2016
Decision Date 12/19/2016
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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