510(k) K960064
K960064 is an FDA 510(k) premarket notification submitted by Bauer Medical, Inc. for the device "TEMNO ACHIEVE BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on April 5, 1996. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Bauer Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1996
- Date Received
- January 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