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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, pacing and cardioversion, temporary, epicardial
510(k) Number K024071
FOIA Releasable 510(k) K024071
Device Name GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact DEBBIE COGAN
Correspondent
GUIDANT CORPORATION, CARDIAC SURGERY
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact DEBBIE COGAN
Regulation Number870.3680
Classification Product Code
NHW  
Date Received12/10/2002
Decision Date 02/14/2003
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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