INEX Absorbable Nasal Implant

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

SPIROX, INC.

The following data is part of a premarket notification filed by Spirox, Inc. with the FDA for Inex Absorbable Nasal Implant.

Pre-market Notification Details

Device IDK152958
510k NumberK152958
Device Name:INEX Absorbable Nasal Implant
ClassificationPolymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant SPIROX, INC. 3475-O EDISON WAY Menlo Park,  CA  94025
ContactMike Rosenthal
CorrespondentMike Rosenthal
SPIROX, INC. 3475-O EDISON WAY Menlo Park,  CA  94025
Product CodeNHB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-07
Decision Date2015-12-04
Summary:summary

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