FDA 510(k), K140116, RESTORELLE Y CONTOUR MESH

FDA 510(k), K140116, RESTORELLE Y CONTOUR MESH

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510(K) Number: K140116
Device Name: RESTORELLE Y CONTOUR MESH
Manufacturer: TIM CRABTREE
Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation Number: OTO
Classification Product Code: KXA
Date Received: 01/16/2014
Decision Date: 02/12/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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