510(k) K843156
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1984
- Date Received
- August 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser For Gastro-Urology Use
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- GU
- Submission Type