ENSIZOR ENDOSCOPIC SCISSORS— 510(k) K141058

Name: FDA 510(k) clearance K141058
Creator: U.S. Food and Drug Administration
Published: 2014-08-01

Substantially Equivalent

Slater Endoscopy, LLC

FDA 510(k) clearance K141058 for ENSIZOR ENDOSCOPIC SCISSORS, Substantially Equivalent on 2014-08-01. Applicant: Slater Endoscopy, LLC. Device class: 2.

Clearance details

Applicant: Slater Endoscopy, LLC
Product code: Code OCZ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2014-04-24
Decision date: 2014-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

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