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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 K063778
Device Name FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
Applicant
Teleflex Medical
2345 Waukegan Rd.
Suite 120
Bannockburn,  IL  60015
Applicant Contact LORI HAYS
Correspondent
Teleflex Medical
2345 Waukegan Rd.
Suite 120
Bannockburn,  IL  60015
Correspondent Contact LORI HAYS
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/21/2006
Decision Date 02/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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