The following data is part of a premarket notification filed by S.a.l.f. Spa with the FDA for Servator H Salf Solution-1000 Ml Pvc Free Bags, Servator H Salf Solution-2000 Ml Pvc Free Bags.
| Device ID | K170150 |
| 510k Number | K170150 |
| Device Name: | Servator H SALF Solution-1000 Ml PVC Free Bags, Servator H SALF Solution-2000 Ml PVC Free Bags |
| Classification | Set, Perfusion, Kidney, Disposable |
| Applicant | S.A.L.F. Spa Via Marconi 2 Cenate Sotto, IT 24069 |
| Contact | Carmelo Gagliano |
| Correspondent | Joyce St. Germain 510k FDA Consulting/Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 |
| Product Code | KDL |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-10-20 |
| Summary: | summary |