510(k) K030820
K030820 is an FDA 510(k) premarket notification submitted by Stick Tech , Ltd. for the device "EVERSTICK POST". The FDA issued a decision of Substantially Equivalent on May 20, 2003. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Stick Tech , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2003
- Date Received
- March 14, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Post, Root Canal
- Device Class
- Class I
- Regulation Number
- 872.3810
- Review Panel
- DE
- Submission Type