TULIP CONDOM— 510(k) K050360

Substantially Equivalent

Shanghai Latex Factory

FDA 510(k) clearance K050360 for TULIP CONDOM, Substantially Equivalent on 2005-03-01. Applicant: Shanghai Latex Factory. Device class: 2.

Clearance details

Applicant: Shanghai Latex Factory
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2005-02-14
Decision date: 2005-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.