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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 K040472
Device Name FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
Applicant
TELEFLEX MEDICAL
2917 Weck Drive
Research Triangle Park,  NC  27709
Applicant Contact ANGELA TRAN
Correspondent
TELEFLEX MEDICAL
2917 Weck Drive
Research Triangle Park,  NC  27709
Correspondent Contact ANGELA TRAN
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/24/2004
Decision Date 03/15/2004
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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