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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
Original Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 paramount dr.
raynham,  MA  02767 0350
Original 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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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