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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name rod, fixation, intramedullary and accessories
510(k) Number K013616
Device Name POLARUS CAP SCREW
Original Applicant
ACUMED, INC.
10950 s.w. 5th st.
suite 170
beaverton,  OR  97005
Original Contact shari jeffers
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/05/2001
Decision Date 12/19/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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