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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 K130016
Device Name LIFESPAN EPTFE VASCULAR GRAFT
Applicant
Lemaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact XIANG ZHANG
Correspondent
Lemaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact XIANG ZHANG
Regulation Number870.3450
Classification Product Code
DSY  
Date Received01/01/2013
Decision Date 02/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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