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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Artery, Intraluminal
510(k) Number K121415
Device Name MOLLRING MULTITASC
Applicant
Lemaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Applicant Contact ANDREW HODGKINSON
Correspondent
Lemaitre Vascular, Inc.
63 2nd Ave.
Bedford,  MA  01803
Correspondent Contact ANDREW HODGKINSON
Regulation Number870.4875
Classification Product Code
DWX  
Date Received05/11/2012
Decision Date 09/05/2012
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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