DISPOSABLE CONCENTRIC NEEDLE ELECTRODE— 510(k) K931029

Name: FDA 510(k) clearance K931029
Creator: U.S. Food and Drug Administration
Published: 1994-08-25

Substantially Equivalent

Chalgren Enterprises, Inc.

FDA 510(k) clearance K931029 for DISPOSABLE CONCENTRIC NEEDLE ELECTRODE, Substantially Equivalent on 1994-08-25. Applicant: Chalgren Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Chalgren Enterprises, Inc.
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 1993-03-01
Decision date: 1994-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gilroy, CA, US

Download summary PDF View on FDA.gov ↗

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