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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 K913271
Device Name OSTEO BONE PLATED
Applicant
Fred C. Bryson
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Applicant Contact FRED C BRYSON
Correspondent
Fred C. Bryson
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Correspondent Contact FRED C BRYSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/23/1991
Decision Date 10/17/1991
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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