The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Oxygenator, Cobe Catalog #42-220.
| Device ID | K790356 |
| 510k Number | K790356 |
| Device Name: | OXYGENATOR, COBE CATALOG #42-220 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-22 |
| Decision Date | 1979-03-09 |