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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ear, Nose And Throat, Synthetic, Absorbable
510(k) Number K192661
Device Name LATERA Absorbable Nasal Implant System
Applicant
Entellus Medical, Inc. (Aka Stryker Ent)
3600 Holly Lane N., Suite 40
Plymouth,  MN  55447
Applicant Contact Karen E. Peterson
Correspondent
Entellus Medical, Inc. (Aka Stryker Ent)
3600 Holly Lane N., Suite 40
Plymouth,  MN  55447
Correspondent Contact Karen E. Peterson
Regulation Number874.3620
Classification Product Code
NHB  
Date Received09/25/2019
Decision Date 11/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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