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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, hemi-, femoral, metal/polymer, cemented or uncemented
510(k) Number K982812
Device Name G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact MARY E GRAY
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact MARY E GRAY
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
JDI   LZO  
Date Received08/11/1998
Decision Date 12/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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