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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K915144
Device Name DEXTER HAND EVALUATION AND THERAPY SYSTEM
Applicant
Cedars Medical Center
1205 Drake Dr. Suite E
P.O. Box 2100
Davis,  CA  95616
Applicant Contact KAREN COMISSO-BOND
Correspondent
Cedars Medical Center
1205 Drake Dr. Suite E
P.O. Box 2100
Davis,  CA  95616
Correspondent Contact KAREN COMISSO-BOND
Regulation Number890.1925
Classification Product Code
IKK  
Date Received11/14/1991
Decision Date 04/02/1992
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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