The following data is part of a premarket notification filed by Analytic Technology with the FDA for Coated Apex Probe.
Device ID | K890735 |
510k Number | K890735 |
Device Name: | COATED APEX PROBE |
Classification | Locator, Root Apex |
Applicant | ANALYTIC TECHNOLOGY 15233 NORTHEAST 90TH ST. Redmond, WA 98052 |
Contact | Johan Masreliez |
Correspondent | Johan Masreliez ANALYTIC TECHNOLOGY 15233 NORTHEAST 90TH ST. Redmond, WA 98052 |
Product Code | LQY |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-13 |
Decision Date | 1989-04-19 |