FDA 510(k) Application Details - K022238

Device Classification Name Instruments, Surgical, Cardiovascular

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510(K) Number K022238
Device Name Instruments, Surgical, Cardiovascular
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MS CW304
MINNEAPOLIS, MN 55432-3576 US
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Contact MARY ELLEN BEST
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Regulation Number 870.4500

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Classification Product Code DWS
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Date Received 07/11/2002
Decision Date 10/09/2002
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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