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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 K861206
Device Name NAUTILUS LEG EXTENSION TESTING & REHABILITATION
Applicant
Nautilus Sports/Medical Industries, Inc.
Post Office Box 1783
Deland,  FL  32720
Applicant Contact ORGAN, M.D.
Correspondent
Nautilus Sports/Medical Industries, Inc.
Post Office Box 1783
Deland,  FL  32720
Correspondent Contact ORGAN, M.D.
Regulation Number890.1925
Classification Product Code
IKK  
Date Received03/31/1986
Decision Date 04/18/1986
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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