FDA 510(k) Application Details - K854325

Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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510(K) Number K854325
Device Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant RICHARDS MEDICAL CO., INC.
1450 BROOKS RD.
MEMPHIS, TN US
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Contact ROBERT F GAMES
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Regulation Number 888.3520

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Classification Product Code HSX
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Date Received 10/28/1985
Decision Date 12/09/1985
Decision SE - Substantially Equivalent
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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