510(k) K013660
K013660 is an FDA 510(k) premarket notification submitted by Radiomed Corporation for the device "GENETRA". The FDA issued a decision of Substantially Equivalent on Dec 5, 2001. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Radiomed Corporation has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 2001
- Date Received
- Nov 6, 2001
- Clearance Type
- Special
- 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)