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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K050418
Device Name TISSUE FIXATION SYSTEM
Original Applicant
TFS MANUFACTURING PTY LTD
18 kincaid avenue
north plympton sa,  AS 5037
Original Contact alastair dowling
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/18/2005
Decision Date 05/16/2005
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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