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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K101611
Device Name RELAY POWER WHEELCHAIR
Applicant
Dalton Instrument Corp.
3788 Arapaho Rd.
Addiison,  TX  75001
Applicant Contact JENNIFER YU
Correspondent
Dalton Instrument Corp.
3788 Arapaho Rd.
Addiison,  TX  75001
Correspondent Contact JENNIFER YU
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/08/2010
Decision Date 09/29/2010
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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