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FDA 510(k) Application Details - K024071
Device Classification Name
Electrode, Pacing And Cardioversion, Temporary, Epicardial
More FDA Info for this Device
510(K) Number
K024071
Device Name
Electrode, Pacing And Cardioversion, Temporary, Epicardial
Applicant
GUIDANT CORPORATION, CARDIAC SURGERY
3200 LAKESIDE DR.
SANTA CLARA, CA 95054 US
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Contact
DEBBIE COGAN
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
NHW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2002
Decision Date
02/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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