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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K111943
Device Name AGILLS PF DELIVERY SYSTEM
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 VALLEY VIEW CT.
SYLMAR,  CA  91342
Applicant Contact GEENA GEORGE
Correspondent
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 VALLEY VIEW CT.
SYLMAR,  CA  91342
Correspondent Contact GEENA GEORGE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/08/2011
Decision Date 09/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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