FDA 510(k) Application Details - K020701

Device Classification Name Electrode, Pacing And Cardioversion, Temporary, Epicardial

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510(K) Number K020701
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
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Regulation Number 870.3680

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Classification Product Code NHW
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Date Received 03/04/2002
Decision Date 05/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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