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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K033639
Device Name ACUMED LOWER EXTREMITY CONGRUENT 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 Number888.3040
Classification Product Code
HWC  
Date Received11/20/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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