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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 K032931
Device Name PTA BALLOON CATHETER
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402 -0489
Applicant Contact KAREN BRADBURN
Correspondent
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402 -0489
Correspondent Contact KAREN BRADBURN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/22/2003
Decision Date 10/22/2003
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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