The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Monolyth C 600 And 1200 Hollow Fiber Membrane Lung With Integrated Softshell Venous Reservoir , Cvr 600 And 1200 Softshe.
| Device ID | K990103 |
| 510k Number | K990103 |
| Device Name: | MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92614 -5751 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-12 |
| Decision Date | 1999-11-05 |
| Summary: | summary |