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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Thigh/Knee/Shank/Ankle/Foot, External
510(k) Number K833868
Device Name IPOS G.L.P. SYSTEM
Applicant
Ipos Luneburg
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ipos Luneburg
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3500
Classification Product Code
KFX  
Date Received11/07/1983
Decision Date 11/28/1983
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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