FDA.reportPublic FDA data

510(k) K230193

Device
Servator P Plus SALF Solution
Applicant
S.A.L.F. Spa
510(k) number
K230193
Product code
KDN
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-21
Date received
2023-01-24
Regulation
876.5880
Classification name
System, Perfusion, Kidney
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carmelo Gagliano
Address
Via Marconi 2 Cenate Sotto IT 24069 24069

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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