The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Icu Conversion Kit.
| Device ID | K902631 |
| 510k Number | K902631 |
| Device Name: | COBE ICU CONVERSION KIT |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | L Armstrong |
| Correspondent | L 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 | 1990-06-14 |
| Decision Date | 1990-12-17 |