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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
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