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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 K871557
Device Name DISCIPLINE II RTD
Applicant
Physio Systems, Inc.
4450 Enterprise St. Suite 101
Fremont,  CA  94538
Applicant Contact DAVID E LIEBERMAN
Correspondent
Physio Systems, Inc.
4450 Enterprise St. Suite 101
Fremont,  CA  94538
Correspondent Contact DAVID E LIEBERMAN
Regulation Number890.1925
Classification Product Code
IKK  
Date Received04/22/1987
Decision Date 08/26/1987
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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