The following data is part of a premarket notification filed by Solution Technologies with the FDA for Dialysol-acid Concentrate Liquid, Granusol-acid Concentrate Powder, Renalsol-acetate Concentrate Liquid & Powder, Biosol.
| Device ID | K981043 |
| 510k Number | K981043 |
| Device Name: | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | SOLUTION TECHNOLOGIES 4825 SOUTH 850 EAST South Ogden, UT 84403 |
| Contact | William J Griswold, Jr |
| Correspondent | William J Griswold, Jr SOLUTION TECHNOLOGIES 4825 SOUTH 850 EAST South Ogden, UT 84403 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-20 |
| Decision Date | 1998-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861101969 | K981043 | 000 |
| 10840861101716 | K981043 | 000 |
| 10840861101709 | K981043 | 000 |
| 10840861101693 | K981043 | 000 |
| 10840861101686 | K981043 | 000 |
| 10840861101679 | K981043 | 000 |
| 10840861101662 | K981043 | 000 |
| 10840861101655 | K981043 | 000 |
| 10840861101648 | K981043 | 000 |
| 10840861101631 | K981043 | 000 |
| 10840861101624 | K981043 | 000 |
| 10840861101723 | K981043 | 000 |
| 10840861101730 | K981043 | 000 |
| 10840861101747 | K981043 | 000 |
| 00840861101955 | K981043 | 000 |
| 00840861101948 | K981043 | 000 |
| 00840861101887 | K981043 | 000 |
| 00840861101870 | K981043 | 000 |
| 00840861101863 | K981043 | 000 |
| 00840861101856 | K981043 | 000 |
| 00840861101849 | K981043 | 000 |
| 00840861101832 | K981043 | 000 |
| 10840861101808 | K981043 | 000 |
| 10840861101754 | K981043 | 000 |
| 10840861101617 | K981043 | 000 |