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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 K123746
Device Name AMES THERAPY DEVICE
Applicant
Ames Technology, Inc.
927 Throne Dr.
Eugene,  OR  97402
Applicant Contact SHEILA RAMERMAN, RAC
Correspondent
Ames Technology, Inc.
927 Throne Dr.
Eugene,  OR  97402
Correspondent Contact SHEILA RAMERMAN, RAC
Regulation Number890.1925
Classification Product Code
IKK  
Subsequent Product Code
IRO  
Date Received12/06/2012
Decision Date 05/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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