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FDA 510(k) Application Details - K022477
Device Classification Name
Microfilter, Blood Transfusion
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
CAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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