COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS— 510(k) K100521

Name: FDA 510(k) clearance K100521
Creator: U.S. Food and Drug Administration
Published: 2010-05-14

Substantially Equivalent

Mego Afek AC , Ltd.

FDA 510(k) clearance K100521 for COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS, Substantially Equivalent on 2010-05-14. Applicant: Mego Afek AC , Ltd.. Device class: 2.

Clearance details

Applicant: Mego Afek AC , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2010-02-23
Decision date: 2010-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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