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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 K031289
Device Name QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
Applicant
Sunrise Medical, Inc.
7477 E. Dry Creek Pkwy.
Longmont,  CO  80503
Applicant Contact MICHAEL CHELLSON
Correspondent
Sunrise Medical, Inc.
7477 E. Dry Creek Pkwy.
Longmont,  CO  80503
Correspondent Contact MICHAEL CHELLSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/23/2003
Decision Date 05/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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