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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name equipment, traction, powered
510(k) Number K900475
Device Name DISTRAC(TM) TABLE
Applicant
LOSSING ORTHOPEDIC, INC.
777 HARDING STREET, N.E. M-4
P.O. BOX 18298
MINNEAPOLIS,  MN  55418
Applicant Contact SUSAN G WOLF
Correspondent
LOSSING ORTHOPEDIC, INC.
777 HARDING STREET, N.E. M-4
P.O. BOX 18298
MINNEAPOLIS,  MN  55418
Correspondent Contact SUSAN G WOLF
Regulation Number890.5900
Classification Product Code
ITH  
Date Received02/01/1990
Decision Date 05/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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