510(k) K981669
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1998
- Date Received
- May 12, 1998
- Clearance Type
- Special
- 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