The following data is part of a premarket notification filed by Dana Laboratories with the FDA for Hemodialysis Concentrate.
| Device ID | K854391 |
| 510k Number | K854391 |
| Device Name: | HEMODIALYSIS CONCENTRATE |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | DANA LABORATORIES 11697 CARDINAL CIRCLE Garden Grove, CA 92643 |
| Contact | Ronald Goodman |
| Correspondent | Ronald Goodman DANA LABORATORIES 11697 CARDINAL CIRCLE Garden Grove, CA 92643 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-31 |
| Decision Date | 1986-01-08 |