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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, Cemented
510(k) Number K983128
Device Name IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
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 Number888.3350
Classification Product Code
JDI  
Date Received09/08/1998
Decision Date 12/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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