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

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.

Clearance details

Applicant: Dura Tap, LLC
Product code: Code NBY
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

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