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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 K020056
Model 436016
Device Name DUET SUTURE ANCHOR
Original Applicant
BIONX IMPLANTS, LTD.
p.o. box 3
herminkatu 6-8l
tampere,  FI sp-33721
Original Contact tuija annala
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/08/2002
Decision Date 06/26/2002
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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