The following data is part of a premarket notification filed by Rockwell Medical Supply with the FDA for Rockwell Medical Supply Llc Hemodialysis Concentrate Solutions & Powders.
| Device ID | K954527 |
| 510k Number | K954527 |
| Device Name: | ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ROCKWELL MEDICAL SUPPLY 28025 OAKLAND OAKS CT. Wixom, MI 48393 |
| Contact | Jeffrey R Shiderman |
| Correspondent | Jeffrey R Shiderman ROCKWELL MEDICAL SUPPLY 28025 OAKLAND OAKS CT. 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 | 1995-09-29 |
| Decision Date | 1996-03-01 |