FDA 510(k) Application Details - K020647

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K020647
Device Name Apparatus, Autotransfusion
Applicant DIDECO S.P.A.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact ROSINA ROBINSON
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 02/28/2002
Decision Date 09/05/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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