510(k) K072296
K072296 is an FDA 510(k) premarket notification submitted by Theragenics Corp. for the device "POIINT OF CARE STRANDING SYSTEM, MODE 1004-00". The FDA issued a decision of Substantially Equivalent on Sep 26, 2007. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Theragenics Corp. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2007
- Date Received
- Aug 17, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Source, Brachytherapy, Radionuclide
- Device Class
- Class II
- Regulation Number
- 892.5730
- Review Panel
- RA
- Submission Type
- 510(k)