510(k) K171953
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2017
- Date Received
- June 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Instrument, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- SU
- Submission Type