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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: 01/16/2014
Date Received: 02/12/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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: 01/16/2014
Date Received: 02/12/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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