510(k) K980248
K980248 is an FDA 510(k) premarket notification submitted by Gallini U.S., LLC for the device "ACRI R NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 18, 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
- Feb 18, 1998
- Date Received
- Jan 23, 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)