ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH— 510(k) K853530

Name: FDA 510(k) clearance K853530
Creator: U.S. Food and Drug Administration
Published: 1985-10-04

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K853530 for ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH, Substantially Equivalent on 1985-10-04. Applicant: E-Z-Em, Inc.. Device class: 2.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1985-08-23
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, US

Download summary PDF View on FDA.gov ↗

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