WoundExpress— 510(k) K211200

Substantially Equivalent

Huntleigh Healthcare , Ltd.

FDA 510(k) clearance K211200 for WoundExpress, Substantially Equivalent on 2021-09-03. Applicant: Huntleigh Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Huntleigh Healthcare , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2021-04-22
Decision date: 2021-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cardiff, GB

Download summary PDF View on FDA.gov ↗

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