510(k) K890735
K890735 is an FDA 510(k) premarket notification submitted by Analytic Technology for the device "COATED APEX PROBE". The FDA issued a decision of Substantially Equivalent on April 19, 1989. The device falls under product code LQY (Locator, Root Apex), a Class U device. Analytic Technology has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1989
- Date Received
- February 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type