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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
Recalls CDRH Recalls
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