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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 K964655
Device Name UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
Applicant
HOWMEDICA CORP.
359 veterans blvd.
rutherford,  NJ  07070
Applicant Contact john dichiara
Correspondent
HOWMEDICA CORP.
359 veterans blvd.
rutherford,  NJ  07070
Correspodent Contact john dichiara
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDL   JWH   LPH  
Date Received11/20/1996
Decision Date 02/06/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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