510(k) K962905
K962905 is an FDA 510(k) premarket notification submitted by Gallini S.R.L. for the device "TX BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on Oct 11, 1996. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 1996
- Date Received
- Jul 25, 1996
- 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
- 510(k)