510(k) K981301
K981301 is an FDA 510(k) premarket notification submitted by Gallini U.S., LLC for the device "SPEED-CUT AUTOMATIC BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 8, 1998. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Gallini U.S., LLC has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 8, 1998
- Date Received
- Apr 9, 1998
- 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
- 510(k)