The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Lilliput Phospholypidic Inert Surface In Oxygenation (ph.i.s.i.o.) Infant Hollow Fibre Oxygenator, Model D902.
| Device ID | K001021 |
| 510k Number | K001021 |
| Device Name: | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-30 |
| Decision Date | 2000-04-25 |