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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 K930834
Device Name ACUTRACT
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Applicant Contact GENE CONRAD
Correspondent
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Correspondent Contact GENE CONRAD
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/17/1993
Decision Date 07/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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