FDA 510(k) Application Details - K093535

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K093535
Device Name Apparatus, Autotransfusion
Applicant MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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Contact CARALEE WALTON
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 11/16/2009
Decision Date 03/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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