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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 K061626
Device Name VASORING* VRC VASCULAR RING CONNECTOR
Applicant
Sunwei Tech Co. , Ltd.
7128 Staffordshire St.
Houston,  TX  77030
Applicant Contact JOSEPH J CHANG
Correspondent
Sunwei Tech Co. , Ltd.
7128 Staffordshire St.
Houston,  TX  77030
Correspondent Contact JOSEPH J CHANG
Regulation Number870.3450
Classification Product Code
DSY  
Date Received06/12/2006
Decision Date 10/05/2006
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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