MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)— 510(k) K130354

Name: FDA 510(k) clearance K130354
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Substantially Equivalent

Entrigue Surgical, Inc.

FDA 510(k) clearance K130354 for MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR), Substantially Equivalent on 2013-05-29. Applicant: Entrigue Surgical, Inc.. Device class: 1.

Clearance details

Applicant: Entrigue Surgical, Inc.
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2013-02-12
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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