FDA 510(k) Application Details - K760842

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

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510(K) Number K760842
Device Name Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant HOWMEDICA CORP.

, US
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Regulation Number 888.3530

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Classification Product Code HRY
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Date Received 10/14/1976
Decision Date 10/20/1976
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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