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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(K) Number K121835
Device Name DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Contact michaela norris
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received06/22/2012
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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