510(k) K131642
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2013
- Date Received
- June 4, 2013
- 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