510(k) K070305
K070305 is an FDA 510(k) premarket notification submitted by Radiomed Corporation for the device "PRE-LOADED VISICOIL". The FDA issued a decision of Substantially Equivalent on Mar 7, 2007. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Radiomed Corporation has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 7, 2007
- Date Received
- Feb 1, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)