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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 K022077
Device Name 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
Applicant
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Applicant Contact JENNIFER A DAUDELIN
Correspondent
Howmedica Osteonics Corp.
59 Rte. 17 S.
Allendale,  NJ  07401
Correspondent Contact JENNIFER A DAUDELIN
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWY   LWJ  
Date Received06/26/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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