510(k) K983218
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1998
- Date Received
- September 14, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type