FDA 510(k) Application Details - K002869

Device Classification Name Computer, Diagnostic, Programmable

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510(K) Number K002869
Device Name Computer, Diagnostic, Programmable
Applicant MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
3850 VICTORIA ST. NORTH
SHOREVIEW, MN 55126 US
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Contact THOMAS PARKER
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Regulation Number 870.1425

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Classification Product Code DQK
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Date Received 09/13/2000
Decision Date 03/27/2001
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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