The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Rockwell Medical Supply,llc. Bicarbonate Solution Concentrates For Bicarbonate Dialysis.
| Device ID | K971053 |
| 510k Number | K971053 |
| Device Name: | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman INTERNATIONAL MEDICAL PRODUCTS, INC. 4503 MOORLAND AVE. Minneapolis, 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 | 1997-03-24 |
| Decision Date | 1997-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814963020094 | K971053 | 000 |
| 00814963020018 | K971053 | 000 |
| 00814963020025 | K971053 | 000 |
| 00814963020032 | K971053 | 000 |
| 00814963020049 | K971053 | 000 |
| 00814963020056 | K971053 | 000 |
| 00814963020063 | K971053 | 000 |
| 00814963020070 | K971053 | 000 |
| 00814963020087 | K971053 | 000 |
| 00814963020001 | K971053 | 000 |