FDA 510(k) Application Details - K963206

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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510(K) Number K963206
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767 US
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Contact JENNIFER L MORSE
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 08/16/1996
Decision Date 10/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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