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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 K880230
Device Name SIXALYZER
Applicant
Lukens Corp.
Ave. Parque Lira #79
Colonia San Miguel Chapultepec
Republica De Mexico 11850,  TX  75261
Applicant Contact LUTZ KAUFFMANN
Correspondent
Lukens Corp.
Ave. Parque Lira #79
Colonia San Miguel Chapultepec
Republica De Mexico 11850,  TX  75261
Correspondent Contact LUTZ KAUFFMANN
Regulation Number890.1925
Classification Product Code
IKK  
Date Received01/20/1988
Decision Date 03/16/1988
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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