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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K151492
Device Name Kudu
Applicant
R82 A/S
Parallelvej 3
Gedved,  DK DK-8751
Applicant Contact Kent Rasmussen
Correspondent
R82 A/S
Parallelvej 3
Gedved,  DK DK-8751
Correspondent Contact Ulla Lange
Regulation Number890.3850
Classification Product Code
IOR  
Subsequent Product Code
LBE  
Date Received06/03/2015
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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