ENDOBRUSH(TM) DEVICE; OMNIBRUSH— 510(k) K897070

Name: FDA 510(k) clearance K897070
Creator: U.S. Food and Drug Administration
Published: 1990-09-10

Substantially Equivalent

Intl. Cytobrush, Inc.

FDA 510(k) clearance K897070 for ENDOBRUSH(TM) DEVICE; OMNIBRUSH, Substantially Equivalent on 1990-09-10. Applicant: Intl. Cytobrush, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Cytobrush, Inc.
Product code: Code HFE
Device class: Class 2
Regulation: 21 CFR 884.1100
Advisory panel: Obstetrics/Gynecology
Date received: 1989-12-22
Decision date: 1990-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, 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.