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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 K013361
Device Name WIN-2 TANGO ELITE NP
Applicant
DURABLE MEDICAL EQUIPMENT, INC.
3636 E. COLUMBINE DR.
PHOENIX,  AZ  85032 -7372
Applicant Contact ROBERT S MCQUATE
Correspondent
DURABLE MEDICAL EQUIPMENT, INC.
3636 E. COLUMBINE DR.
PHOENIX,  AZ  85032 -7372
Correspondent Contact ROBERT S MCQUATE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/10/2001
Decision Date 02/26/2002
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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