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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K820476
Device Name KEM-2
Applicant
Medical Graphics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Graphics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/19/1982
Decision Date 03/08/1982
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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