The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Cml3.
| Device ID | K880021 |
| 510k Number | K880021 |
| Device Name: | COBE CML3 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Dennis Bruner,phd |
| Correspondent | Dennis Bruner,phd COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-05 |
| Decision Date | 1988-04-01 |