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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 K001039
Device Name THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
Applicant
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact JOHN SCHALAGO
Correspondent
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact JOHN SCHALAGO
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received03/31/2000
Decision Date 06/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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