TRUE-TRAC, STRATUS— 510(k) K926316

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K926316 for TRUE-TRAC, STRATUS, Substantially Equivalent on 1993-03-24. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant: Henley Intl.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 1992-12-15
Decision date: 1993-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, 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.