The following data is part of a premarket notification filed by International Medical Products, Inc. with the FDA for Rockwell Medical Supply, Llc. Dri-sate Acid Concentrate Mixes.
| Device ID | K981003 |
| 510k Number | K981003 |
| Device Name: | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES |
| 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 | 1998-03-18 |
| Decision Date | 1998-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814963021404 | K981003 | 000 |
| 00814963020605 | K981003 | 000 |
| 00814963020599 | K981003 | 000 |
| 00814963020582 | K981003 | 000 |
| 00814963020575 | K981003 | 000 |
| 00814963020568 | K981003 | 000 |
| 00814963020551 | K981003 | 000 |
| 00814963020544 | K981003 | 000 |
| 00814963020537 | K981003 | 000 |
| 00814963020520 | K981003 | 000 |
| 00814963020513 | K981003 | 000 |
| 00814963020506 | K981003 | 000 |
| 00814963020612 | K981003 | 000 |
| 00814963020629 | K981003 | 000 |
| 00814963020636 | K981003 | 000 |
| 00814963021398 | K981003 | 000 |
| 00814963021381 | K981003 | 000 |
| 00814963021329 | K981003 | 000 |
| 00814963021312 | K981003 | 000 |
| 00814963021190 | K981003 | 000 |
| 00814963020698 | K981003 | 000 |
| 00814963020681 | K981003 | 000 |
| 00814963020674 | K981003 | 000 |
| 00814963020667 | K981003 | 000 |
| 00814963020650 | K981003 | 000 |
| 00814963020643 | K981003 | 000 |
| 00814963020490 | K981003 | 000 |