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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(K) Number K083651
Device Name REVELATION STEM, MODEL 427-21/42-080/180
Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin,  TX  78758
Contact teffany hutto
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
KWZ   LPH   LZO  
Date Received12/09/2008
Decision Date 03/13/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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