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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 K033654
Device Name FORCE FIBER
Applicant
TELEFLEX MEDICAL
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Applicant Contact LYNN MATOS
Correspondent
TELEFLEX MEDICAL
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Correspondent Contact LYNN MATOS
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/21/2003
Decision Date 01/15/2004
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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