FDA 510(k) Application Details - K013982

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

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510(K) Number K013982
Device Name Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Applicant KINAMED, INC.
820 FLYNN RD.
CAMARILLO, CA 93012 US
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Contact VINEET SARIN
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Regulation Number 888.3540

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Classification Product Code KRR
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Date Received 12/03/2001
Decision Date 05/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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