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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 K122538
Device Name ACUMED PELVIC BONE PLATE SYSTEM
Original Applicant
ACUMED LLC
5885 nw cornelius pass rd
hillsboro,  OR  97124
Original Contact kara budor
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/21/2012
Decision Date 11/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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