Psoria-Shield AURORA— 510(k) K192411

Substantially Equivalent

Psoria-Shield

FDA 510(k) clearance K192411 for Psoria-Shield AURORA, Substantially Equivalent on 2020-07-02. Applicant: Psoria-Shield. Device class: 2.

Clearance details

Applicant: Psoria-Shield
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2019-09-04
Decision date: 2020-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Utica, 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.