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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Cast
510(k) Number K840617
Device Name MASTERFOOT CAST HEEL
Applicant
SETON PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SETON PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.5940
Classification Product Code
LGF  
Date Received02/13/1984
Decision Date 03/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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