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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 K896553
Device Name MEDX CERVICAL EXTENSION TEST & REHAB MACHINE
Applicant
Medx Corp.
1155 NE 77th St.
Ocala,  FL  32670
Applicant Contact WILLIAM JONES
Correspondent
Medx Corp.
1155 NE 77th St.
Ocala,  FL  32670
Correspondent Contact WILLIAM JONES
Regulation Number890.1925
Classification Product Code
IKK  
Date Received11/17/1989
Decision Date 01/02/1990
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
Recalls CDRH Recalls
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