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.
| Device ID | K202652 |
| 510k Number | K202652 |
| Device Name: | Servator P SALF Solution With THAM |
| Classification | System, Perfusion, Kidney |
| Applicant | S.A.L.F. Spa Via Marconi 2 Cenate Sotto, IT 24069 |
| Contact | Carmelo Gagliano |
| Correspondent | Joyce St. Germain The 510k Consulting, LLC 1449 Springleaf Drive Ormond Beach, FL 32174 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-08-19 |