510(k) K041428
K041428 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ACCUSOL DIALYSIS SOLUTION". The FDA issued a decision of Substantially Equivalent on Aug 27, 2004. The device falls under product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 27, 2004
- Date Received
- May 28, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)