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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 K050280
Device Name RUNABOUT WHEELCHAIR
Applicant
Access Point Medical, LLC
9109 Copenhaver Dr.
Potomac,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
Access Point Medical, LLC
9109 Copenhaver Dr.
Potomac,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/07/2005
Decision Date 04/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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