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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K042984
Device Name INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
Applicant
Intervascular
690 Canton St., Suite 302
Canton,  MA  02090
Applicant Contact Amy Aulwes
Correspondent
Intervascular
690 Canton St., Suite 302
Canton,  MA  02090
Correspondent Contact Amy Aulwes
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/29/2004
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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