510(k) K033767
K033767 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "DUAL TOP ANCHOR SYSTEM SCREWS". The FDA issued a decision of Substantially Equivalent on Feb 24, 2004. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 24, 2004
- Date Received
- Dec 3, 2003
- 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
- 510(k)