The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Empty Dialysate Container Bb-69.
| Device ID | K830689 |
| 510k Number | K830689 |
| Device Name: | EMPTY DIALYSATE CONTAINER BB-69 |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | DELMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-03-29 |