TAN MATE HOME TANNING UNIT— 510(k) K861107

Name: FDA 510(k) clearance K861107
Creator: U.S. Food and Drug Administration
Published: 1986-04-25

Substantially Equivalent

Specialty Engineering, Inc.

FDA 510(k) clearance K861107 for TAN MATE HOME TANNING UNIT, Substantially Equivalent on 1986-04-25. Applicant: Specialty Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Engineering, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1986-03-24
Decision date: 1986-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maplewood, MN, US

Download summary PDF View on FDA.gov ↗

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