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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 K162794
Device Name Gelweave Vascular Grafts
Applicant
Vascutek, Ltd.
Newmains Ave.
Inchinnan,  GB PA49RR
Applicant Contact NEIL MCLACHLAN
Correspondent
Vascutek, Ltd.
Newmains Ave.
Inchinnan,  GB PA49RR
Correspondent Contact NEIL MCLACHLAN
Regulation Number870.3450
Classification Product Code
DSY  
Date Received10/04/2016
Decision Date 06/30/2017
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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