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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 K070673
Device Name FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
Applicant
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact ELIZABETH LANDON
Correspondent
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact ELIZABETH LANDON
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/12/2007
Decision Date 04/02/2007
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
Predetermined Change
Control Plan Authorized		 No
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