FDA 510(k) Application Details - K952830

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

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510(K) Number K952830
Device Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC.
ROUTE 202 N.
RARITAN, NJ 08869 US
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Contact JOHN D FERROS
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Regulation Number 888.3560

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Classification Product Code JWH
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Date Received 06/20/1995
Decision Date 01/18/1996
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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