The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Dideco Lilliput 1 Twin Reservoir With Phosphorilcholine Insert Surface In Oxygenation (ph. I.s.i.o.).
| Device ID | K001602 |
| 510k Number | K001602 |
| Device Name: | DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) |
| 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 | 2000-05-24 |
| Decision Date | 2000-06-08 |