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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 K020701
Device Name SYNCRUS INTERNAL CARDIOVERSION SYSTEM
Applicant
Guidant Corporation, Cardiac Surgery
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Applicant Contact DEBBIE COGAN
Correspondent
Guidant Corporation, Cardiac Surgery
3200 Lakeside Dr.
S,Mta Clara,  CA  95054
Correspondent Contact DEBBIE COGAN
Regulation Number870.3680
Classification Product Code
NHW  
Date Received03/04/2002
Decision Date 05/24/2002
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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