LOOK PTFE Suture— 510(k) K160744

Name: FDA 510(k) clearance K160744
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Substantially Equivalent

Surgical Specialties Corporation

FDA 510(k) clearance K160744 for LOOK PTFE Suture, Substantially Equivalent on 2016-07-13. Applicant: Surgical Specialties Corporation. Device class: 2.

Clearance details

Applicant: Surgical Specialties Corporation
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2016-03-17
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tijuana, MX

Download summary PDF View on FDA.gov ↗

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