The following data is part of a premarket notification filed by Dideco S.r.l. with the FDA for Lilliput 1 New Born Hollow Fiber Oxygenator.
| Device ID | K953835 |
| 510k Number | K953835 |
| Device Name: | LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.R.L. 200 WEST STREET Waltham, MA 02451 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-16 |
| Decision Date | 1996-03-15 |