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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K071944
Device Name ACUMED SMALL BONE LOCKING SYSTEM II
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 Number888.3020
Classification Product Code
HSB  
Date Received07/13/2007
Decision Date 08/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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