SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7— 510(k) K031053

Name: FDA 510(k) clearance K031053
Creator: U.S. Food and Drug Administration
Published: 2003-05-20

Substantially Equivalent

Selectivemed Components, Inc.

FDA 510(k) clearance K031053 for SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7, Substantially Equivalent on 2003-05-20. Applicant: Selectivemed Components, Inc.. Device class: 2.

Clearance details

Applicant: Selectivemed Components, Inc.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2003-04-02
Decision date: 2003-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Vernon, OH, US

Download summary PDF View on FDA.gov ↗

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