METEC HELARIUM LOUNGE & SKY UNITS— 510(k) K812225

Name: FDA 510(k) clearance K812225
Creator: U.S. Food and Drug Administration
Published: 1982-03-15

Substantially Equivalent

Klafs Sunlight Corp.

FDA 510(k) clearance K812225 for METEC HELARIUM LOUNGE & SKY UNITS, Substantially Equivalent on 1982-03-15. Applicant: Klafs Sunlight Corp.. Device class: 2.

Clearance details

Applicant: Klafs Sunlight Corp.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1981-08-10
Decision date: 1982-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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