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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Exoskeleton
510(k) Number K201539
Device Name Keeogo Dermoskeleton System
Applicant
B-Temia, Inc.
4780, Rue St-Felix - Unite 105
St-Augustin-De-Desmaures,  CA G3A2J9
Applicant Contact Alexandre Jokic
Correspondent
Covington & Burling, Llp
850 10th St. NW
Washington,  DC  20001
Correspondent Contact Kristin Davenport
Regulation Number890.3480
Classification Product Code
PHL  
Date Received06/09/2020
Decision Date 09/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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