510(k) K103319
K103319 is an FDA 510(k) premarket notification submitted by Theragenics Corp. for the device "I-SEED". The FDA issued a decision of Substantially Equivalent on Jan 3, 2011. 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
- Jan 3, 2011
- Date Received
- Nov 12, 2010
- 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)