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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 K852977
Device Name KNEE MACHINE
Applicant
Kaiser Medical
7504 W. Ridge Rd.
Eluria,  OH  44035
Applicant Contact ROBERT T KAISER
Correspondent
Kaiser Medical
7504 W. Ridge Rd.
Eluria,  OH  44035
Correspondent Contact ROBERT T KAISER
Regulation Number890.5380
Classification Product Code
BXB  
Date Received07/15/1985
Decision Date 10/16/1985
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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