FDA 510(k) Application Details - K992723

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K992723
Device Name Apparatus, Autotransfusion
Applicant TRANSFUSION TECHNOLOGIES CORP.
9 ERIE DR.
NATICK, MA 01760 US
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Contact JOHN J SOKOLOWSKI
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 08/13/1999
Decision Date 10/18/1999
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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