FDA 510(k) Application Details - K041525

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K041525
Device Name Apparatus, Autotransfusion
Applicant ZIMMER, INC.
PO BOX 10 200 W. OHIO AVENUE
DOVER, OH 44622-0010 US
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Contact CINDY J DICKEY
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 06/08/2004
Decision Date 10/14/2004
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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