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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 K901210
Device Name BOUNDER VA POWER WHEELCHAIR
Applicant
21st Century Scientific, Inc.
7629 Fulton Ave.
North Hollywood,  CA  91605
Applicant Contact PRIOR, PHD
Correspondent
21st Century Scientific, Inc.
7629 Fulton Ave.
North Hollywood,  CA  91605
Correspondent Contact PRIOR, PHD
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/14/1990
Decision Date 03/26/1990
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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