I.S.M. PRODUCT FAMILY MODEL R3600C— 510(k) K854170

Name: FDA 510(k) clearance K854170
Creator: U.S. Food and Drug Administration
Published: 1985-11-08

Substantially Equivalent

Intl. Solarium Manufacturer, Inc.

FDA 510(k) clearance K854170 for I.S.M. PRODUCT FAMILY MODEL R3600C, Substantially Equivalent on 1985-11-08. Applicant: Intl. Solarium Manufacturer, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Solarium Manufacturer, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1985-10-15
Decision date: 1985-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Hollywood, CA, US

Download summary PDF View on FDA.gov ↗

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