GOLNIT Non-Absorbable PTFE Surgical Suture— 510(k) K163049

Name: FDA 510(k) clearance K163049
Creator: U.S. Food and Drug Administration
Published: 2017-06-21

Substantially Equivalent

Antarma Dba Golnit Sutures

FDA 510(k) clearance K163049 for GOLNIT Non-Absorbable PTFE Surgical Suture, Substantially Equivalent on 2017-06-21. Applicant: Antarma Dba Golnit Sutures. Device class: 2.

Clearance details

Applicant: Antarma Dba Golnit Sutures
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2016-11-01
Decision date: 2017-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

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K191317 — StitchKit2019-07-12
K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture2018-10-11

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