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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 K113300
Model ATB
Device Name ATB ADVANCE PTA DILATATION CATHETER
Original Applicant
COOK, INC.
750 daniels way
blmgtn,  IN  47404
Original Contact elysia poor
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received11/09/2011
Decision Date 12/09/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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