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FDA 510(k), K132920, SPIROX INEX DEVICE
FDA 510(k), K132920, SPIROX INEX DEVICE
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510(K) Number: K132920
Device Name: SPIROX INEX DEVICE
Manufacturer: SPIROX, INC.
Device Classification Name: polymer, ear, nose and throat, synthetic, absorbable
Regulation Number: 874.3620
Classification Product Code: NHB
Date Received: 09/17/2013
Decision Date: 06/10/2014
Regulation Medical Specialty: Ear Nose & Throat
Device Name: SPIROX INEX DEVICE
Manufacturer: SPIROX, INC.
Device Classification Name: polymer, ear, nose and throat, synthetic, absorbable
Regulation Number: 874.3620
Classification Product Code: NHB
Date Received: 09/17/2013
Decision Date: 06/10/2014
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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