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FDA 510(k), K141816, HEMOPORE
FDA 510(k), K141816, HEMOPORE
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510(K) Number: K141816
Device Name: HEMOPORE
Manufacturer: Polyganics BV
Device Classification Name: splint, intranasal septal
Regulation Number: 874.4780
Classification Product Code: LYA
Date Received: 07/07/2014
Decision Date: 10/23/2014
Regulation Medical Specialty: Ear Nose & Throat
Device Name: HEMOPORE
Manufacturer: Polyganics BV
Device Classification Name: splint, intranasal septal
Regulation Number: 874.4780
Classification Product Code: LYA
Date Received: 07/07/2014
Decision Date: 10/23/2014
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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