510(k) K811209
K811209 is an FDA 510(k) premarket notification submitted by Colmed, Ltd. for the device "JACOB WIRZ TRANSFIXATION PIN". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code ELS (Splint, Endodontic Stabilizing), a Class II device regulated under 21 CFR 872.3890. Colmed, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1981
- Date Received
- May 1, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Endodontic Stabilizing
- Device Class
- Class II
- Regulation Number
- 872.3890
- Review Panel
- DE
- Submission Type