The following data is part of a premarket notification filed by Rockwell Medical Technologies, Inc. with the FDA for Rockwell Medicaltechnologies, Inc. Citrapure.
| Device ID | K062399 |
| 510k Number | K062399 |
| Device Name: | ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ROCKWELL MEDICAL TECHNOLOGIES, INC. 30142 WIXOM RD. Wixom, MI 48393 |
| Contact | Rob Chioini |
| Correspondent | Rob Chioini 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 | 2006-08-16 |
| Decision Date | 2006-11-17 |
| Summary: | summary |