FDA 510(k) Application Details - K961520

Device Classification Name Electrode, Pacemaker, Temporary

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510(K) Number K961520
Device Name Electrode, Pacemaker, Temporary
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432-3576 US
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Contact VALERIE K STUHR
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Regulation Number 870.3680

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Classification Product Code LDF
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Date Received 04/22/1996
Decision Date 11/13/1996
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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