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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 K051083
Device Name ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
Applicant
ACUMED LLC
5885 NW CORNELIUS PASS RD.
HILLSBORO,  OR  97124 -9432
Applicant Contact ED BOEHMER
Correspondent
ACUMED LLC
5885 NW CORNELIUS PASS RD.
HILLSBORO,  OR  97124 -9432
Correspondent Contact ED BOEHMER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/27/2005
Decision Date 05/12/2005
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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