GOLNIT Non-aborbable PTFE Surgical Suture— 510(k) K192088

Name: FDA 510(k) clearance K192088
Creator: U.S. Food and Drug Administration
Published: 2019-09-04

Substantially Equivalent

Antarma, LLC Dba Golnit Sutures

FDA 510(k) clearance K192088 for GOLNIT Non-aborbable PTFE Surgical Suture, Substantially Equivalent on 2019-09-04. Applicant: Antarma, LLC Dba Golnit Sutures. Device class: 2.

Clearance details

Applicant: Antarma, LLC Dba Golnit Sutures
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2019-08-05
Decision date: 2019-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.