FDA 510(k) Application Details - K972894

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K972894
Device Name Apparatus, Autotransfusion
Applicant MEDTRONIC BLOOD MANAGEMENT
18501 EAST PLAZA DR.
PARKER, CO 80134-9061 US
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Contact JOYCE THOMAS
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 08/05/1997
Decision Date 04/27/1998
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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