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FDA 510(k), K130354, MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
FDA 510(k), K130354, MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
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510(K) Number: K130354
Device Name: MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
Manufacturer: ENTRIGUE SURGICAL, INC.
Device Classification Name: splint, intranasal septal
Regulation Number: 874.4780
Classification Product Code: LYA
Date Received: 02/12/2013
Decision Date: 05/29/2013
Regulation Medical Specialty: Ear Nose & Throat
Device Name: MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
Manufacturer: ENTRIGUE SURGICAL, INC.
Device Classification Name: splint, intranasal septal
Regulation Number: 874.4780
Classification Product Code: LYA
Date Received: 02/12/2013
Decision Date: 05/29/2013
Regulation Medical Specialty: Ear Nose & Throat
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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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