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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 K030999
Device Name EPTFE VASCULAR PROSTHESIS; SEALPTFE
Applicant
Vascutek, Ltd.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact STEVEN ARICK
Correspondent
Vascutek, Ltd.
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact STEVEN ARICK
Regulation Number870.3450
Classification Product Code
DSY  
Date Received03/31/2003
Decision Date 04/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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