The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Sh14 Hemoconcentrator.
| Device ID | K081313 |
| 510k Number | K081313 |
| Device Name: | SH14 HEMOCONCENTRATOR |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-09 |
| Decision Date | 2008-11-19 |
| Summary: | summary |