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FDA 510(k) Application Details - K951311
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K951311
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
COBE RENAL CARE, INC.
1185 OAK ST.
LAKEWOOD, CO 80215-4407 US
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Contact
JEFFREY R SHIDEMAN
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Regulation Number
876.5860
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Classification Product Code
KDI
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More FDA Info for this Product Code
Date Received
03/22/1995
Decision Date
01/11/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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