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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 K791408
Device Name MAINSTREAM ELEVATING WHEEL CHAIR
Applicant
Summit Services, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Summit Services, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/26/1979
Decision Date 08/10/1979
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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