The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cms Vrb-1200.
| Device ID | K895076 |
| 510k Number | K895076 |
| Device Name: | CMS VRB-1200 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Mary Armstrong |
| Correspondent | Mary Armstrong COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1989-11-03 |