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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 K191268
Device Name Force Fiber Suture
Applicant
Teleflex Medical Incorporated
375 Forbes Boulevard
Mansfield,  MA  02048
Applicant Contact Andrea Curria
Correspondent
Teleflex Medical Incorporated
375 Forbes Boulevard
Mansfield,  MA  02048
Correspondent Contact Andrea Curria
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/13/2019
Decision Date 06/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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