510(k) K974018
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1998
- Date Received
- October 22, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type