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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K094044
Device Name SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
Applicant
Tayside Flow Technologies Limited
1141 E. Hawken Way
Chandler,  AZ  85286
Applicant Contact RUDY MOUNIA
Correspondent
Tayside Flow Technologies Limited
1141 E. Hawken Way
Chandler,  AZ  85286
Correspondent Contact RUDY MOUNIA
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/31/2009
Decision Date 03/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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