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FDA 510(k) Application Details - K100334
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K100334
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
B. BRAUN AVITUM AG
901 MARCON BOULEVARD
ALLENTOWN, PA 18109 US
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Contact
ANGELA J CARAVELLA
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
02/05/2010
Decision Date
04/22/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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