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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 K013022
Device Name SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
Applicant
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Applicant Contact LISA PETERSON
Correspondent
Sulzer Carbomedics, Inc.
1300 E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact LISA PETERSON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/07/2001
Decision Date 06/13/2002
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
Recalls CDRH Recalls
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