510(k) K063843
K063843 is an FDA 510(k) premarket notification submitted by Medicnrg , Ltd. for the device "APEXNRG XFR". The FDA issued a decision of Substantially Equivalent on January 3, 2007. The device falls under product code LQY (Locator, Root Apex), a Class U device. Medicnrg , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2007
- Date Received
- December 26, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type