The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Variable Prime Cobe Membrane Lung.
| Device ID | K842908 |
| 510k Number | K842908 |
| Device Name: | VARIABLE PRIME COBE MEMBRANE LUNG |
| Classification | Oxygenator, 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 | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-24 |
| Decision Date | 1985-02-01 |