The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Onguard 1000, Catalog #043611-000 & 043611-001.
| Device ID | K870976 |
| 510k Number | K870976 |
| Device Name: | ONGUARD 1000, CATALOG #043611-000 & 043611-001 |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-10 |
| Decision Date | 1987-05-06 |