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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K101740
Device Name ALBOSURE POLYESTER VASCULAR PATCH
Applicant
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact VIC ZHANG
Correspondent
LeMaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact VIC ZHANG
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received06/21/2010
Decision Date 09/20/2010
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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