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 |