The following data is part of a premarket notification filed by Rockwell Medical Technologies, Inc. with the FDA for Bicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 Gallon.
| Device ID | K022521 |
| 510k Number | K022521 |
| Device Name: | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ROCKWELL MEDICAL TECHNOLOGIES, INC. 30142 WIXOM RD. Wixom, MI 48393 |
| Contact | Donald Danald |
| Correspondent | Donald Danald ROCKWELL MEDICAL TECHNOLOGIES, INC. 30142 WIXOM RD. Wixom, MI 48393 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-30 |
| Decision Date | 2003-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814963021459 | K022521 | 000 |