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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 K873659
Device Name MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO
Applicant
Universal Gym Equipment, Inc.
C/O Darby & Darby
405 Lexington Ave.
New York,  NY  10174
Applicant Contact GORDON D COPLEIN
Correspondent
Universal Gym Equipment, Inc.
C/O Darby & Darby
405 Lexington Ave.
New York,  NY  10174
Correspondent Contact GORDON D COPLEIN
Regulation Number890.1925
Classification Product Code
IKK  
Date Received09/10/1987
Decision Date 04/21/1988
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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