The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Cardiotomy Reservoir With Or Without Filter.
| Device ID | K902437 |
| 510k Number | K902437 |
| Device Name: | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada, CO 80004 |
| Contact | L Armstrong |
| Correspondent | L Armstrong COBE LABORATORIES, INC. 14401 WEST 56TH WAY Arvada, CO 80004 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178250376 | K902437 | 000 |
| 38033178109674 | K902437 | 000 |