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FDA 510(k), K132061, RESTORELLE M, RESTORELLE XL
FDA 510(k), K132061, RESTORELLE M, RESTORELLE XL
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$149.00 USD
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510(K) Number: K132061
Device Name: RESTORELLE M, RESTORELLE XL
Manufacturer: TIM CRABTREE
Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation Number: OTO
Classification Product Code: 07/03/2013
Date Received: 08/02/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: RESTORELLE M, RESTORELLE XL
Manufacturer: TIM CRABTREE
Device Classification Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Regulation Number: OTO
Classification Product Code: 07/03/2013
Date Received: 08/02/2013
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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