FDA 510(k) Application Details - K022477

Device Classification Name Microfilter, Blood Transfusion

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510(K) Number K022477
Device Name Microfilter, Blood Transfusion
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 880.5440

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Classification Product Code CAK
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Date Received 07/29/2002
Decision Date 10/25/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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