The following data is part of a premarket notification filed by Physicians Surgeons Purchasing Group with the FDA for Hemodialysis Concentrate Formulations/additives.
| Device ID | K860296 |
| 510k Number | K860296 |
| Device Name: | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | PHYSICIANS SURGEONS PURCHASING GROUP 8927 SOUTH VERMONT AVE. Los Angeles, CA 90044 |
| Contact | Mack Macdonald |
| Correspondent | Mack Macdonald PHYSICIANS SURGEONS PURCHASING GROUP 8927 SOUTH VERMONT AVE. Los Angeles, CA 90044 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-03-04 |