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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 K915613
Device Name BONE SCREW 3.5 MM
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Applicant Contact RANDALL HUEBNER
Correspondent
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON,  OR  97005
Correspondent Contact RANDALL HUEBNER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/16/1991
Decision Date 02/13/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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