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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 K980286
Device Name ULTIMA ACETABULAR ROOF REINFORCEMENT RING
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact JANET G JOHNSON
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact JANET G JOHNSON
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/26/1998
Decision Date 04/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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