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FDA 510(k) Application Details - K970446
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K970446
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
13520 S.E. PHEASANT COURT
PORTLAND, OR 97222-1298 US
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THOMAS D KELLY
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
02/05/1997
Decision Date
06/02/1997
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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