510(k) K954658
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1996
- Date Received
- October 10, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Aneurysm Clip
- Device Class
- Class II
- Regulation Number
- 882.4175
- Review Panel
- NE
- Submission Type