SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY— 510(k) K850660

Name: FDA 510(k) clearance K850660
Creator: U.S. Food and Drug Administration
Published: 1985-03-01

Substantially Equivalent

Suntech USA, Inc.

FDA 510(k) clearance K850660 for SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY, Substantially Equivalent on 1985-03-01. Applicant: Suntech USA, Inc.. Device class: 2.

Clearance details

Applicant: Suntech USA, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1985-02-20
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jacksonville, IL, US

Download summary PDF View on FDA.gov ↗

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