510(k) K860863
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1986
- Date Received
- March 7, 1986
- 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