KAEN YIH UMBILICAL CORD CLAMP— 510(k) K033846

Name: FDA 510(k) clearance K033846
Creator: U.S. Food and Drug Administration
Published: 2004-03-11

Substantially Equivalent

Kaen Yih Enterprise Co., Ltd.

FDA 510(k) clearance K033846 for KAEN YIH UMBILICAL CORD CLAMP, Substantially Equivalent on 2004-03-11. Applicant: Kaen Yih Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kaen Yih Enterprise Co., Ltd.
Product code: Code HFW
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2003-12-11
Decision date: 2004-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mc Henry, IL, US

Download summary PDF View on FDA.gov ↗

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