510(k) K945295
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1995
- Date Received
- October 31, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type