510(k) K061201
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2006
- Date Received
- May 1, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy, Suction
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type