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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K112697
Device Name CHARGER PTA BALLON DILATATION CATHETER
Original Applicant
BOSTON SCIENTIFIC
one scimed place
maple grove,  MN  55311 -1566
Original Contact glenn jacques
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received09/16/2011
Decision Date 11/30/2011
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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