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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K130354
Device Name MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
Applicant
ENTRIGUE SURGICAL, INC.
12672 SILICON DR. STE 150
SAN ANTONIO,  TX  78249
Applicant Contact GABRIELE G NIEDERAUER
Correspondent
ENTRIGUE SURGICAL, INC.
12672 SILICON DR. STE 150
SAN ANTONIO,  TX  78249
Correspondent Contact GABRIELE G NIEDERAUER
Regulation Number874.4780
Classification Product Code
LYA  
Date Received02/12/2013
Decision Date 05/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT01733667
Reviewed by Third Party No
Combination Product No
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