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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 K010395
Device Name E-POWER
Applicant
DALTON MEDICAL CORP.
1103 VENTURE CT.
CARROLLTON,  TX  75006
Applicant Contact WILL RIDGWAY
Correspondent
DALTON MEDICAL CORP.
1103 VENTURE CT.
CARROLLTON,  TX  75006
Correspondent Contact WILL RIDGWAY
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/09/2001
Decision Date 05/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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