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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 K122940
Device Name ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
Applicant
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact ELYSIA EASTON
Correspondent
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact ELYSIA EASTON
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received09/24/2012
Decision Date 03/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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