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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, Uncemented
510(k) Number K001471
Device Name THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Applicant Contact JOHN A SCHALAGO
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Correspondent Contact JOHN A SCHALAGO
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
LPH  
Date Received05/11/2000
Decision Date 08/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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