510(k) K040129
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2004
- Date Received
- January 21, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type