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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K942260
Device Name ALDEN WHEELCHAIR CUSHION
Applicant
Ward and Assoc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Ward and Assoc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number890.3920
Classification Product Code
KNN  
Date Received05/09/1994
Decision Date 05/26/1994
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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