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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K132047
Device Name LEMILLS VALVULOTOME
Applicant
Lemaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Applicant Contact ANDREW HODGKINSON
Correspondent
Lemaitre Vascular, Inc.
63 Second Ave.
Burlington,  MA  01803
Correspondent Contact ANDREW HODGKINSON
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received07/02/2013
Decision Date 11/05/2013
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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