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FDA 510(k) Application Details - K990643
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K990643
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
14620 N.W. 60TH AVE.
MIAMI LAKES, FL 33014-9308 US
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Contact
AMAURY SANCHEZ
Other 510(k) Applications for this Contact
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
02/26/1999
Decision Date
12/07/1999
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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