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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Twister, Brace Setting
510(k) Number K800716
Device Name ORTHOTIC LEG GAIT CORRECTOR DEVICE
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 Number890.3410
Classification Product Code
ITO  
Date Received03/31/1980
Decision Date 05/02/1980
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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