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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
510(k) Number K965156
Device Name ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact SALLY MAHER
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact SALLY MAHER
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Code
LZY  
Date Received12/23/1996
Decision Date 01/24/1997
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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