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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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