510(k) K024120
K024120 is an FDA 510(k) premarket notification submitted by Allegiance Healthcare Corp. for the device "MODIFICATION TO TEMNO BIOPSY NEEDLES". The FDA issued a decision of Substantially Equivalent on January 15, 2003. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Allegiance Healthcare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2003
- Date Received
- December 16, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type