The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Accusol Dialysis Solution.
| Device ID | K041428 |
| 510k Number | K041428 |
| Device Name: | ACCUSOL DIALYSIS SOLUTION |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-28 |
| Decision Date | 2004-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09349285000178 | K041428 | 000 |
| 09349285000161 | K041428 | 000 |
| 09349285000154 | K041428 | 000 |