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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Corrective Shoe
510(k) Number K831690
Device Name IPOS ANTI-ADDUCTUS SHOE
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 Number890.3475
Classification Product Code
KNP  
Date Received05/24/1983
Decision Date 06/24/1983
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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