510(k) K882746
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1989
- Date Received
- July 5, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type