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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 K832161
Device Name AMBULIZER MODEL MC-5
Applicant
Mobilizer Medical Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mobilizer Medical Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/05/1983
Decision Date 08/01/1983
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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