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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 K161638
Device Name SPEEDTRAP Graft Preparation System
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Jeffrey Dzialo
Correspondent
Depuy Mitek, A Johnson and Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Jeffrey Dzialo
Regulation Number878.5000
Classification Product Code
GAT  
Date Received06/14/2016
Decision Date 11/07/2016
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
Predetermined Change
Control Plan Authorized		 No
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