ELITE SYSTEM— 510(k) K911416

Substantially Equivalent

Gfb Intl. Trading, Inc.

FDA 510(k) clearance K911416 for ELITE SYSTEM, Substantially Equivalent on 1991-06-06. Applicant: Gfb Intl. Trading, Inc.. Device class: 2.

Clearance details

Applicant: Gfb Intl. Trading, Inc.
Product code: Code LXJ
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1991-04-01
Decision date: 1991-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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