FDA 510(k), K022077, 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

FDA 510(k), K022077, 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)

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510(K) Number: K022077
Device Name: 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
Manufacturer: JENNIFER A DAUDELIN
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation Number: JDI
Classification Product Code: KXA
Date Received: 06/26/2002
Decision Date: 07/25/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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