510(k) K873367
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1987
- Date Received
- August 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 876.4480
- Review Panel
- GU
- Submission Type