Servator P SALF Solution With THAM

System, Perfusion, Kidney

S.A.L.F. Spa

The following data is part of a premarket notification filed by S.a.l.f. Spa with the FDA for Servator P Salf Solution With Tham.

Pre-market Notification Details

Device IDK202652
510k NumberK202652
Device Name:Servator P SALF Solution With THAM
ClassificationSystem, Perfusion, Kidney
Applicant S.A.L.F. Spa Via Marconi 2 Cenate Sotto,  IT 24069
ContactCarmelo Gagliano
CorrespondentJoyce St. Germain
The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach,  FL  32174
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2021-08-19

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