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 ID: K192661
• 510k Number: K192661
• Device Name: LATERA Absorbable Nasal Implant System
• Classification: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
• Applicant: Entellus Medical, Inc. (Aka Stryker ENT) 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
• Contact: Karen E. Peterson
• Correspondent: Karen E. Peterson; Entellus Medical, Inc. (Aka Stryker ENT) 3600 Holly Lane North, Suite 40 Plymouth, MN 55447
• Product Code: NHB
• CFR Regulation Number: 874.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-25
• Decision Date: 2019-11-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857037006020	K192661	000
00857037006037	K192661	000
00857037006013	K192661	000