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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 K921369
Device Name BIOMEDICAL HORIZONS MODEL 1001
Applicant
Biomedical Horizons, Inc.
P.O. Box 889
Jackson,  MI  49204
Applicant Contact WILLIAM DONAHUE
Correspondent
Biomedical Horizons, Inc.
P.O. Box 889
Jackson,  MI  49204
Correspondent Contact WILLIAM DONAHUE
Regulation Number890.3920
Classification Product Code
KNN  
Date Received03/20/1992
Decision Date 05/11/1992
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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