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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
FOIA Releasable 510(k) K050418
Device Name TISSUE FIXATION SYSTEM
Applicant
Tfs Manufacturing Pty, Ltd.
18 Kincaid Ave.
North Plympton Sa,  AU 5037
Applicant Contact ALASTAIR DOWLING
Correspondent
Tfs Manufacturing Pty, Ltd.
18 Kincaid Ave.
North Plympton Sa,  AU 5037
Correspondent Contact ALASTAIR DOWLING
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/18/2005
Decision Date 05/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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