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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, cutting/scoring
510(k) Number K141322
Device Name ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
Applicant
COOK INCORPORATED
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact STEVEN LAWRIE
Correspondent
COOK INCORPORATED
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact STEVEN LAWRIE
Regulation Number870.1250
Classification Product Code
PNO  
Date Received05/20/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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