510(k) K993840
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2000
- Date Received
- November 12, 1999
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Catheter, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.5470
- Review Panel
- GU
- Submission Type