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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 K903252
Device Name BROAD SELF-COMPRESSING PLATE
Applicant
Onyx Medical Corp.
152 Collins St.
Memphis,  TN  38112
Applicant Contact GEORGE W MURRAY
Correspondent
Onyx Medical Corp.
152 Collins St.
Memphis,  TN  38112
Correspondent Contact GEORGE W MURRAY
Regulation Number888.3030
Classification Product Code
HRS  
Date Received07/24/1990
Decision Date 08/09/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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