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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
Applicant
ENCORE MEDICAL CORPORATION
11201 PEPPER ROAD
HUNT VALLEY,  MD  21031
Applicant Contact SAM SON
Correspondent
ENCORE MEDICAL CORPORATION
11201 PEPPER ROAD
HUNT VALLEY,  MD  21031
Correspondent Contact SAM SON
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LPH  
LWJ   LZO  
Date Received08/25/2005
Decision Date 12/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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