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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Positioning, Electric
510(k) Number K101723
Device Name COMPACT WHEELCHAIR PLATFORM
Applicant
Design Specific Fletcher
Unit 10 Caburn Enterprise Park
The Broyle
Ringmer East Sussex,  GB BN8 5NP
Applicant Contact RICHARD FLETCHER
Correspondent
Design Specific Fletcher
Unit 10 Caburn Enterprise Park
The Broyle
Ringmer East Sussex,  GB BN8 5NP
Correspondent Contact RICHARD FLETCHER
Regulation Number890.3110
Classification Product Code
INO  
Date Received06/18/2010
Decision Date 12/23/2010
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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