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 |