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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 K003048
Device Name ALL TERRAIN WHEELCHAIR (ATW)
Applicant
Roll-Ability (Pty) , Ltd.
6162 Steeplechase Dr.
Roanoke,  VA  24018
Applicant Contact VICTOR F MYBURGH
Correspondent
Roll-Ability (Pty) , Ltd.
6162 Steeplechase Dr.
Roanoke,  VA  24018
Correspondent Contact VICTOR F MYBURGH
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/29/2000
Decision Date 12/15/2000
Decision Substantially Equivalent (SESE)
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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