The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Mvr 1200 Pc: Sorin Monolyth Venous Reservoir 1200 Pc With Phosphorylcholine Coating.
| Device ID | K033714 |
| 510k Number | K033714 |
| Device Name: | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2003-12-11 |
| Summary: | summary |