FDA 510(k) Application Details - K953200

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

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510(K) Number K953200
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact J. TERESA DORRIETY
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 07/10/1995
Decision Date 01/31/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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