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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 K152868
Device Name ExpressBraid Graft Manipulation
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE PO BOX 587
WARSAW,  IL  46581
Applicant Contact ADAM CARGILL
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE PO BOX 587
WARSAW,  IL  46581
Correspondent Contact ADAM CARGILL
Regulation Number878.5000
Classification Product Code
GAT  
Date Received09/30/2015
Decision Date 02/08/2016
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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