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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 K150438
Device Name Force Fiber OrthoTape suture
Applicant
Teleflexmedical, Inc.
Oem
375 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact VLADISLAVA ZAITSEVA
Correspondent
Teleflexmedical, Inc.
Oem
375 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact VLADISLAVA ZAITSEVA
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/19/2015
Decision Date 04/02/2015
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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