510(k) K071614
K071614 is an FDA 510(k) premarket notification submitted by Civco for the device "FIDUCIAL MARKERS". The FDA issued a decision of Substantially Equivalent on Sep 11, 2007. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Civco has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 2007
- Date Received
- Jun 13, 2007
- Clearance Type
- Traditional
- 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)