DemeTECH PTFE Nonabsorbable Surgical Suture— 510(k) K181578

Name: FDA 510(k) clearance K181578
Creator: U.S. Food and Drug Administration
Published: 2018-10-11

Substantially Equivalent

Demetech Corporation

FDA 510(k) clearance K181578 for DemeTECH PTFE Nonabsorbable Surgical Suture, Substantially Equivalent on 2018-10-11. Applicant: Demetech Corporation. Device class: 2.

Clearance details

Applicant: Demetech Corporation
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2018-06-15
Decision date: 2018-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

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K180630 — PTFE SURGICAL SUTURE2018-04-06

More clearances from Demetech Corporation

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K181582 — DemeTECH DemeDIOX absorbable surgical suture2018-08-27

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