The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Ak-10-udm-10-a Ultradiffusion.
| Device ID | K800425 |
| 510k Number | K800425 |
| Device Name: | GAMBRO AK-10-UDM-10-A ULTRADIFFUSION |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | GAMBRO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-26 |
| Decision Date | 1980-04-08 |