The following data is part of a premarket notification filed by Solution Technologies with the FDA for Hemsol-acid Concentrate Liquid Hemogran Acid Concentrate Powder, Nephrosol-acetate Concentrate Powder, Bicarbosol-bicare.
| Device ID | K982378 |
| 510k Number | K982378 |
| Device Name: | HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE |
| 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 | 1998-07-08 |
| Decision Date | 1998-08-26 |