The following data is part of a premarket notification filed by Rockwell Medical Technologies, Inc. with the FDA for Dri-sate Mixer For Preparation Of Acidified Dialysate Concentrate.
| Device ID | K983618 |
| 510k Number | K983618 |
| Device Name: | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ROCKWELL MEDICAL TECHNOLOGIES, INC. 28025 OAKLAND OAKS CT. Wixom, MI 48393 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman ROCKWELL MEDICAL TECHNOLOGIES, INC. 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 | 1998-10-15 |
| Decision Date | 1999-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814963021442 | K983618 | 000 |
| 00814963021435 | K983618 | 000 |