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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, peripheral, atherectomy
510(k) Number K120346
Device Name CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Original Applicant
REX MEDICAL
55 northern blvd.
suite 200
great neck,  NY  11021
Original Contact susan d goldstein-falk
Regulation Number870.4875
Classification Product Code
MCW  
Date Received02/03/2012
Decision Date 06/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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