LEESPEC DISPOSABLE VAGINAL SPECULUM— 510(k) K021017

Name: FDA 510(k) clearance K021017
Creator: U.S. Food and Drug Administration
Published: 2002-06-19

Substantially Equivalent

Itl Corporation Pty, Ltd.

FDA 510(k) clearance K021017 for LEESPEC DISPOSABLE VAGINAL SPECULUM, Substantially Equivalent on 2002-06-19. Applicant: Itl Corporation Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Itl Corporation Pty, Ltd.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2002-03-29
Decision date: 2002-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fyshwick, Canberra Act, AU

Download summary PDF View on FDA.gov ↗

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