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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 K163651
Device Name ExpressBraid Graft Manipulation
Applicant
Biomet Manufacturing Corp.
56 East Bell Drive
PO Box 587
Warsaw,  IN  46581
Applicant Contact Vinay Bhal
Correspondent
Biomet Manufacturing Corp.
56 East Bell Drive
PO Box 587
Warsaw,  IN  46581
Correspondent Contact Vinay Bhal
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/23/2016
Decision Date 02/17/2017
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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