510(k) K954529
K954529 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "AUTOMATED TRU-CUT BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on Dec 29, 1995. 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
- Dec 29, 1995
- Date Received
- Sep 29, 1995
- 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)