The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Rockwell Medical Supply, Llc. Concentrate Solutions For Acetate Dialysate.
| Device ID | K973253 |
| 510k Number | K973253 |
| Device Name: | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | INTERNATIONAL MEDICAL PRODUCTS, INC. 7307 GLOUCHESTER DR. Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman INTERNATIONAL MEDICAL PRODUCTS, INC. 7307 GLOUCHESTER DR. Edina, MN 55435 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1997-10-30 |
| Summary: | summary |