EASY LOOP, MODEL EZL-01— 510(k) K040110

Substantially Equivalent

Tools For Surgery, LLC

FDA 510(k) clearance K040110 for EASY LOOP, MODEL EZL-01, Substantially Equivalent on 2004-03-24. Applicant: Tools For Surgery, LLC. Device class: 2.

Clearance details

Applicant: Tools For Surgery, LLC
Product code: Code EZP
Device class: Class 2
Regulation: 21 CFR 876.4270
Advisory panel: Gastroenterology, Urology
Date received: 2004-01-20
Decision date: 2004-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, 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.