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/newborn Hollow Fiber Oxygenator.
| Device ID | K991737 |
| 510k Number | K991737 |
| Device Name: | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO S.P.A. 1601 TRAPELO RD. Waltham, MA 02154 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 1601 TRAPELO RD. Waltham, MA 02154 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-21 |
| Decision Date | 2000-02-17 |
| Summary: | summary |