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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 K931688
Device Name SEMI-TUBULAR PLATE
Original Applicant
ONYX MEDICAL CORP.
152 collins st.
memphis,  TN  38112
Original Contact laraine b gilmore
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/05/1993
Decision Date 04/25/1994
Decision substantially equivalent for some indications (SN)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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