HTR POLYMER, HTR-MX— 510(k) K904111

Name: FDA 510(k) clearance K904111
Creator: U.S. Food and Drug Administration
Published: 1990-11-23

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K904111 for HTR POLYMER, HTR-MX, Substantially Equivalent on 1990-11-23. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1990-09-06
Decision date: 1990-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, 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.