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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 K944732
Device Name DEXTER ISOKINETIC
Applicant
Cedaron Medical, Inc.
P.O. Box 2100
Davis,  CA  95617
Applicant Contact KAREN BOND
Correspondent
Cedaron Medical, Inc.
P.O. Box 2100
Davis,  CA  95617
Correspondent Contact KAREN BOND
Regulation Number890.1925
Classification Product Code
IKK  
Date Received08/25/1994
Decision Date 02/03/1995
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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