VEINWAVE, TC3000— 510(k) K083352

Name: FDA 510(k) clearance K083352
Creator: U.S. Food and Drug Administration
Published: 2009-06-12

Substantially Equivalent

Newlands Clinical Trials, Ltd.

FDA 510(k) clearance K083352 for VEINWAVE, TC3000, Substantially Equivalent on 2009-06-12. Applicant: Newlands Clinical Trials, Ltd.. Device class: 2.

Clearance details

Applicant: Newlands Clinical Trials, Ltd.
Product code: Code ONQ
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2008-11-13
Decision date: 2009-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, NH, US

Download summary PDF View on FDA.gov ↗

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