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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K000678
Device Name RAEBBITT/EVOLUTION POWERED WHEELCHAIR
Applicant
Otto Bock Orthopedic Industry, Inc.
3000 Xenium Ln., Suite N
Plymouth,  MN  55441
Applicant Contact WILLIAM JACKSON
Correspondent
Otto Bock Orthopedic Industry, Inc.
3000 Xenium Ln., Suite N
Plymouth,  MN  55441
Correspondent Contact WILLIAM JACKSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/29/2000
Decision Date 09/18/2000
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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