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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 K140042
Device Name 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
Applicant
LEMAITRE VASCULAR, INC.
63 SECOND AVENUE
BURLINGTON,  MA  01803
Applicant Contact BRYAN COWELL
Correspondent
LEMAITRE VASCULAR, INC.
63 SECOND AVENUE
BURLINGTON,  MA  01803
Correspondent Contact BRYAN COWELL
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received01/08/2014
Decision Date 04/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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