Gazelle PTFE and Suture Delivery Device— 510(k) K173335

Name: FDA 510(k) clearance K173335
Creator: U.S. Food and Drug Administration
Published: 2018-02-08

Substantially Equivalent

Dura Tap, LLC

FDA 510(k) clearance K173335 for Gazelle PTFE and Suture Delivery Device, Substantially Equivalent on 2018-02-08. Applicant: Dura Tap, LLC. Device class: 2.

Clearance details

Applicant: Dura Tap, LLC
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2017-10-23
Decision date: 2018-02-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wayne, PA, US

Download summary PDF View on FDA.gov ↗

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