LATERA Absorbable Nasal Implant System

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Entellus Medical, Inc. (Aka Stryker ENT)

The following data is part of a premarket notification filed by Entellus Medical, Inc. (aka Stryker Ent) with the FDA for Latera Absorbable Nasal Implant System.

Pre-market Notification Details

Device IDK192661
501k NumberK192661
Device Name:LATERA Absorbable Nasal Implant System
ClassificationPolymer, Ear, Nose And Throat, Synthetic, Absorbable
Applicant Entellus Medical, Inc. (Aka Stryker ENT) 3600 Holly Lane North, Suite 40 Plymouth,  MN  55447
ContactKaren E. Peterson
CorrespondentKaren E. Peterson
Entellus Medical, Inc. (Aka Stryker ENT) 3600 Holly Lane North, Suite 40 Plymouth,  MN  55447
Product CodeNHB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
501k Review PanelEar Nose & Throat
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-25
Decision Date2019-11-10

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