The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Gas Filter.
| Device ID | K851289 |
| 510k Number | K851289 |
| Device Name: | COBE GAS FILTER |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Holland Hickey |
| Correspondent | Holland Hickey COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-06-19 |