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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wheelchair, mechanical
510(k) Number K120391
Device Name MR4500 WHEELCHAIR
Applicant
WARDRAY PREMISE LTD
7 VILLAGE WOODS DR
AMHERST,  NH  03031
Applicant Contact JAMES WASON PH.D.
Correspondent
WARDRAY PREMISE LTD
7 VILLAGE WOODS DR
AMHERST,  NH  03031
Correspondent Contact JAMES WASON PH.D.
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/07/2012
Decision Date 12/21/2012
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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