510(k) K963750
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1996
- Date Received
- September 18, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Flexible
- Device Class
- Class II
- Regulation Number
- 876.4680
- Review Panel
- GU
- Submission Type