510(k) K090581
K090581 is an FDA 510(k) premarket notification submitted by Halifax Biomedical, Inc. for the device "TANTALUM BEAD SET, MODEL P003175". The FDA issued a decision of Substantially Equivalent on Aug 21, 2009. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Halifax Biomedical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 21, 2009
- Date Received
- Mar 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Radiographic, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
- 510(k)