NON-STERILE DISPOSABLE VAGINAL SPECULUM— 510(k) K092870

Name: FDA 510(k) clearance K092870
Creator: U.S. Food and Drug Administration
Published: 2010-02-16

Substantially Equivalent

Kunshan Deyi Plastic Co., Ltd.

FDA 510(k) clearance K092870 for NON-STERILE DISPOSABLE VAGINAL SPECULUM, Substantially Equivalent on 2010-02-16. Applicant: Kunshan Deyi Plastic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kunshan Deyi Plastic Co., Ltd.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2009-09-18
Decision date: 2010-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Echo, OR, US

Download summary PDF View on FDA.gov ↗

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