510(k) K896404
K896404 is an FDA 510(k) premarket notification submitted by Optik for the device "TITAMED ANTWERP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Optik has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1990
- Date Received
- November 7, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type