510(k) K052254
K052254 is an FDA 510(k) premarket notification submitted by Brainbase Corporation for the device "MYTIS ARROW XXXX". The FDA issued a decision of Substantially Equivalent on June 1, 2006. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Brainbase Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2006
- Date Received
- August 18, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type