The following data is part of a premarket notification filed by Advanced Renal Technologies, Inc. with the FDA for Art Bicarbonate For Hemodialysis, Art Bicarbonate Liquid For Hemodialysis.
| Device ID | K010760 |
| 510k Number | K010760 |
| Device Name: | ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ADVANCED RENAL TECHNOLOGIES, INC. 11838 N.E. 112TH ST. Kirkland, WA 98033 |
| Contact | Robin Callan |
| Correspondent | Robin Callan ADVANCED RENAL TECHNOLOGIES, INC. 11838 N.E. 112TH ST. Kirkland, WA 98033 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-06-11 |