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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K941966
Device Name CAT SCOOTER
Applicant
Genus Medical, Inc.
441-A Applewood Cres
Concord, Ont,  CA
Applicant Contact NELSON PANG
Correspondent
Genus Medical, Inc.
441-A Applewood Cres
Concord, Ont,  CA
Correspondent Contact NELSON PANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/22/1994
Decision Date 05/06/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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