The following data is part of a premarket notification filed by Edlaw Pharmaceuticals, Inc. with the FDA for Hemodialysate.
| Device ID | K813388 |
| 510k Number | K813388 |
| Device Name: | HEMODIALYSATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | EDLAW PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-02 |
| Decision Date | 1981-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10857940006596 | K813388 | 000 |
| 00857940006681 | K813388 | 000 |
| 00857940006674 | K813388 | 000 |