FDA 510(k) Application Details - K024097

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K024097
Device Name Apparatus, Autotransfusion
Applicant SUMMIT MEDICAL LTD.
BUSINESS & TECHNOLOGY CENTRE
BESSEMER DRIVE
STEVENAGE HERTFORDSHIRE SGI 2DX GB
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Contact NEIL R ARMSTRONG
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 12/12/2002
Decision Date 02/14/2003
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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