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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K994083
Device Name STANNAH POWER CHAIR, MODEL 201
Applicant
Stannah Power Chairs , Ltd.
Watt Close
East Portway Ind. Estate
Andover, Hampshire,  GB SP10 3SD
Applicant Contact CHARLES EDGELL
Correspondent
Stannah Power Chairs , Ltd.
Watt Close
East Portway Ind. Estate
Andover, Hampshire,  GB SP10 3SD
Correspondent Contact CHARLES EDGELL
Regulation Number890.3900
Classification Product Code
IPL  
Date Received12/03/1999
Decision Date 04/04/2001
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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