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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
Applicant Contact LYNN MATOS
Correspondent
Teleflex Medical
600 Airport Rd.
Fall River,  MA  02720
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
Predetermined Change
Control Plan Authorized		 No
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