510(k) K990953
K990953 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "RENAL LINK". The FDA issued a decision of Substantially Equivalent on Jun 18, 1999. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 1999
- Date Received
- Mar 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Semi-Automatic, Peritoneal
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)