CYTOLOGY BRUSH— 510(k) K914504

Name: FDA 510(k) clearance K914504
Creator: U.S. Food and Drug Administration
Published: 1992-02-18

Substantially Equivalent

Surgitek Medical Engineering Corp.

FDA 510(k) clearance K914504 for CYTOLOGY BRUSH, Substantially Equivalent on 1992-02-18. Applicant: Surgitek Medical Engineering Corp.. Device class: 2.

Clearance details

Applicant: Surgitek Medical Engineering Corp.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-09
Decision date: 1992-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

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