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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 K950815
Device Name CHAMPION
Applicant
Kleinfeld, Kaplan and Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact BONNIE B ANDERSON
Correspondent
Kleinfeld, Kaplan and Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact BONNIE B ANDERSON
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/22/1995
Decision Date 05/12/1995
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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