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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K090256
Device Name POWER STANDING DANI
Applicant
DAVISMADE, INC.
2511 DAVISON RD
FLINT,  MI  48506
Applicant Contact DANIEL DAVIS
Correspondent
DAVISMADE, INC.
2511 DAVISON RD
FLINT,  MI  48506
Correspondent Contact DANIEL DAVIS
Regulation Number890.3900
Classification Product Code
IPL  
Date Received02/02/2009
Decision Date 07/06/2009
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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