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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 K931244
Device Name BONE PLATE
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Correspondent
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/11/1993
Decision Date 02/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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