FDA 510(k), K132920, SPIROX INEX DEVICE
FDA 510(k), K132920, SPIROX INEX DEVICE
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
Total pages: 2,214
Fully redacted pages: 1,932
Content pages: 282
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