The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Cms-hf Hollow Fiber Membrane Oxygenator.
| Device ID | K923272 |
| 510k Number | K923272 |
| Device Name: | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada, CO 80004 |
| Contact | Mary Armstrong |
| Correspondent | Mary Armstrong COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada, CO 80004 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1993-05-11 |