The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Single-needle Controller #18-756.
| Device ID | K820173 |
| 510k Number | K820173 |
| Device Name: | COBE SINGLE-NEEDLE CONTROLLER #18-756 |
| Classification | Set, Dialysis, Single Needle With Uni-directional Pump |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-21 |
| Decision Date | 1982-03-23 |