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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K761150
Device Name GALLENAUGH BONE PLATES
Applicant
ORTHOPEDIC EQUIPMENT CO., INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
ORTHOPEDIC EQUIPMENT CO., INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/26/1976
Decision Date 12/16/1976
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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