510(k) K960509
K960509 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "18 GAUGE TRU-CUT BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on Apr 4, 1996. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 4, 1996
- Date Received
- Feb 5, 1996
- 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)