510(k) K010283
K010283 is an FDA 510(k) premarket notification submitted by Theragenics Corp. for the device "THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200". The FDA issued a decision of Substantially Equivalent on April 26, 2001. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Theragenics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2001
- Date Received
- January 30, 2001
- Clearance Type
- Traditional
- 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