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 |