GONGDONG DISPOSABLE VAGINAL SPECULUM— 510(k) K050887

Name: FDA 510(k) clearance K050887
Creator: U.S. Food and Drug Administration
Published: 2005-07-11

Substantially Equivalent

Zhejiang Gongdong Medical Plastic Factory

FDA 510(k) clearance K050887 for GONGDONG DISPOSABLE VAGINAL SPECULUM, Substantially Equivalent on 2005-07-11. Applicant: Zhejiang Gongdong Medical Plastic Factory. Device class: 2.

Clearance details

Applicant: Zhejiang Gongdong Medical Plastic Factory
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2005-04-07
Decision date: 2005-07-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Huangyan, Taizhou, Zhejiang, CN

Download summary PDF View on FDA.gov ↗

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