The following data is part of a premarket notification filed by Althin Medical Ab with the FDA for Althin Medical Ab Altracart Ii.
| Device ID | K990010 |
| 510k Number | K990010 |
| Device Name: | ALTHIN MEDICAL AB ALTRACART II |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ALTHIN MEDICAL AB BOX 39, (FRIDHEMSV. 15) 372 21 Ronneby, SE 372 21 |
| Contact | Ulf Lundgren |
| Correspondent | Ulf Lundgren ALTHIN MEDICAL AB BOX 39, (FRIDHEMSV. 15) 372 21 Ronneby, SE 372 21 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-04-15 |
| Summary: | summary |