SKIN-LITE— 510(k) K843300

Substantially Equivalent

Guardian Chemical

FDA 510(k) clearance K843300 for SKIN-LITE, Substantially Equivalent on 1984-11-07. Applicant: Guardian Chemical. Device class: 1.

Clearance details

Applicant: Guardian Chemical
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1984-08-23
Decision date: 1984-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithtown, 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.