The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Sorin Monolyrh Integrated Membrane Lung.
| Device ID | K922933 |
| 510k Number | K922933 |
| Device Name: | SORIN MONOLYRH INTEGRATED MEMBRANE LUNG |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
| Contact | Lori E Adels |
| Correspondent | Lori E Adels SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1992-11-30 |