COMFORT/IO IONTOPHORESIS ELECTRODES— 510(k) K060579

Name: FDA 510(k) clearance K060579
Creator: U.S. Food and Drug Administration
Published: 2006-04-20

Substantially Equivalent

Pepin Mfg., Inc.

FDA 510(k) clearance K060579 for COMFORT/IO IONTOPHORESIS ELECTRODES, Substantially Equivalent on 2006-04-20. Applicant: Pepin Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Pepin Mfg., Inc.
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 2006-03-06
Decision date: 2006-04-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

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