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FDA 510(k) Application Details - K070320
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K070320
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
EDWARDS LIFESCIENCES SERVICES GMBH
BUSINESS & TECHNOLOGY CENTER
BESSEMER DRIVE
STEVENAGE, HERTSFORDSHIRE SG1 2DX GB
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Contact
NEIL R ARMSTRONG
Other 510(k) Applications for this Contact
Regulation Number
876.5860
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Classification Product Code
KDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2007
Decision Date
06/07/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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