510(k) K902526
K902526 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481". The FDA issued a decision of Substantially Equivalent on Nov 20, 1990. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), 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
- Nov 20, 1990
- Date Received
- Jun 5, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Administration, For Peritoneal Dialysis, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)