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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/polymer, porous uncemented
510(k) Number K992109
Device Name ENCORE FULLY COATED HIP
Applicant
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact DEBBIE DE LOS SANTOS
Correspondent
ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact DEBBIE DE LOS SANTOS
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received06/22/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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