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 |