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FDA 510(k) Application Details - K043342
Device Classification Name
Dialyzer, Capillary, Hollow Fiber
More FDA Info for this Device
510(K) Number
K043342
Device Name
Dialyzer, Capillary, Hollow Fiber
Applicant
GAMBRO RENAL PRODUCTS
10810 WEST COLLINS AVE.
LAKEWOOD, CO 80215 US
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Contact
KAE MILLER
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Regulation Number
876.5820
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Classification Product Code
FJI
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More FDA Info for this Product Code
Date Received
12/06/2004
Decision Date
05/27/2005
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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