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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K121839
Device Name UNBALLOON NON-OCCLUSIVE MODELING CATHETER
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 Number870.1250
Classification Product Code
DQY  
Date Received06/22/2012
Decision Date 08/08/2012
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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