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FDA 510(k), K220281, multiFiltratePRO System
FDA 510(k), K220281, multiFiltratePRO System
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$49.00 USD
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$49.00 USD
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510(K) Number: K220281
Device Name: multiFiltratePRO System
Manufacturer: Denise Oppermann
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 02/01/2022
Decision Date: 12/16/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: multiFiltratePRO System
Manufacturer: Denise Oppermann
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: KDI
Classification Product Code: KXA
Date Received: 02/01/2022
Decision Date: 12/16/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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