JEL-20— 510(k) K012303

Substantially Equivalent

J.F. Jelenko & Co., Inc.

FDA 510(k) clearance K012303 for JEL-20, Substantially Equivalent on 2001-08-22. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.

Clearance details

Applicant: J.F. Jelenko & Co., Inc.
Product code: Code EJS
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2001-07-20
Decision date: 2001-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJS

K041433 — BRIGHT GOLD XH2004-08-19
K040436 — SIMIDUR SUPERIOR2004-03-05
K022252 — STERNGOLD 1, MODEL 11277812002-09-19
K022469 — ECO E42002-09-18
K021367 — STERNGOLD 66, MODEL #11802302002-05-16

More clearances from J.F. Jelenko & Co., Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.