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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
Original Applicant
LEMAITRE VASCULAR INC.
63 second avenue
bedford,  MA  01803
Original 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
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