HANDIFLEX— 510(k) K971046

Substantially Equivalent

Handiflex Corp.

FDA 510(k) clearance K971046 for HANDIFLEX, Substantially Equivalent on 1997-09-16. Applicant: Handiflex Corp.. Device class: 2.

Clearance details

Applicant: Handiflex Corp.
Product code: Code JFB
Device class: Class 2
Regulation: 21 CFR 890.5880
Advisory panel: Physical Medicine
Date received: 1997-03-21
Decision date: 1997-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davie, FL, 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.