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FDA 510(k) Application Details - K963933
Device Classification Name
Dialyzer, Capillary, Hollow Fiber
More FDA Info for this Device
510(K) Number
K963933
Device Name
Dialyzer, Capillary, Hollow Fiber
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
ANN MARIE PAHLMAN
Other 510(k) Applications for this Contact
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
10/01/1996
Decision Date
11/24/1997
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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