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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, iontophoresis, other uses
510(k) Number K192749
Device Name Dermadry
Dermadry Laboratories inc.
9223 Langelier Blvd
Montreal,  CA H1P 3K9
Applicant Contact Maxime Calouche
LOK North America Inc.
2025 Michelin Street
Laval,  CA H7L5B7
Correspondent Contact Louis-Paul Marin
Regulation Number890.5525
Classification Product Code
Date Received09/30/2019
Decision Date 02/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No