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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 K021075
Device Name MECHANICAL DAILY USE WHEELCHAIR
Applicant
First World Services, Inc.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Applicant Contact LEONARD FRIER
Correspondent
First World Services, Inc.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Correspondent Contact LEONARD FRIER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/02/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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