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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 K844060
Device Name ISOSTATION ANKLE/SUBTALAR MACHINE A-100
Applicant
Isotechnologies, Inc.
P.O. Box 1239
Hillsborough,  NC  27278
Applicant Contact MARTIN
Correspondent
Isotechnologies, Inc.
P.O. Box 1239
Hillsborough,  NC  27278
Correspondent Contact MARTIN
Regulation Number890.1925
Classification Product Code
IKK  
Date Received10/18/1984
Decision Date 11/23/1984
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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