510(k) K022068
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2002
- Date Received
- June 25, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Dialysate
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type