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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 K172016
Device Name Force Fiber Fusion Suture
Applicant
Teleflex Medical Incorporated
375 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact Vladislava Zaitseva
Correspondent
Teleflex Medical Incorporated
375 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact Vladislava Zaitseva
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/03/2017
Decision Date 10/03/2017
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
Predetermined Change
Control Plan Authorized		 No
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