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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 K942359
Device Name BONE PLATE SYSTEM
Original Applicant
ACUMED, INC.
10950 s.w. 5th st.
suite 170
beaverton,  OR  97005
Original Contact shari jeffers
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/17/1994
Decision Date 04/13/1995
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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