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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 K052320
Device Name ENCORE CLP OFFSET TOTAL HIP SYSTEM
Original Applicant
ENCORE MEDICAL CORPORATION
11201 pepper road
hunt valley,  MD  21031
Original Contact sam son
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received08/29/2005
Decision Date 12/30/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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