510(k) K042900
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2004
- Date Received
- October 19, 2004
- 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