The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Centry 2 Ultrafiltration Control Kit, #018762-002.
| Device ID | K881062 |
| 510k Number | K881062 |
| Device Name: | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 |
| Classification | Detector, Dialysate Level |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | FJB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-04-21 |