510(k) K942544
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1994
- Date Received
- May 31, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Biliary Mechanical
- Device Class
- Class II
- Regulation Number
- 876.4500
- Review Panel
- GU
- Submission Type