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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 K872199
Device Name DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER
Applicant
Dyno-Max Co.
12600 San Pablo Ave. #A
Richmond,  CA  94805
Applicant Contact DAVID R SCHULTZ
Correspondent
Dyno-Max Co.
12600 San Pablo Ave. #A
Richmond,  CA  94805
Correspondent Contact DAVID R SCHULTZ
Regulation Number890.1925
Classification Product Code
IKK  
Date Received06/08/1987
Decision Date 08/21/1987
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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