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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 K905525
Device Name CYBEX 6000
Applicant
Cybex
2100 Smithtown Ave.
P.O. Box 9003
Ronkonkoma,  NY  11779
Applicant Contact WILLIAM SAUER
Correspondent
Cybex
2100 Smithtown Ave.
P.O. Box 9003
Ronkonkoma,  NY  11779
Correspondent Contact WILLIAM SAUER
Regulation Number890.1925
Classification Product Code
IKK  
Date Received12/10/1990
Decision Date 02/14/1991
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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