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FDA 510(k) Application Details - K231406
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K231406
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
Bellco Srl
Via Camurana 1
Mirandola 41037 IT
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Contact
Rekha Roveri
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
05/15/2023
Decision Date
06/14/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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