510(k) K890735

COATED APEX PROBE by Analytic Technology — Product Code LQY

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