TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM— 510(k) K063728

Name: FDA 510(k) clearance K063728
Creator: U.S. Food and Drug Administration
Published: 2007-04-04

Substantially Equivalent

Alfa Tech Medical Systems, Ltd.

FDA 510(k) clearance K063728 for TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM, Substantially Equivalent on 2007-04-04. Applicant: Alfa Tech Medical Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Alfa Tech Medical Systems, Ltd.
Product code: Code IMG
Device class: Class 2
Regulation: 21 CFR 890.5860
Advisory panel: Physical Medicine
Date received: 2006-12-15
Decision date: 2007-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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