ULTATHIN FLEXIBLE ENDOSCOPE— 510(k) K941715

Name: FDA 510(k) clearance K941715
Creator: U.S. Food and Drug Administration
Published: 1994-10-04

Substantially Equivalent

Technology Marketing Group

FDA 510(k) clearance K941715 for ULTATHIN FLEXIBLE ENDOSCOPE, Substantially Equivalent on 1994-10-04. Applicant: Technology Marketing Group. Device class: 2.

Clearance details

Applicant: Technology Marketing Group
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-07
Decision date: 1994-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maywood, NJ, US

Download summary PDF View on FDA.gov ↗

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