RUBBER CONTRACEPTIVE (CONDOM)— 510(k) K896142

Name: FDA 510(k) clearance K896142
Creator: U.S. Food and Drug Administration
Published: 1990-06-06

Substantially Equivalent

Guangzhou No. 11 Rubber Factory

FDA 510(k) clearance K896142 for RUBBER CONTRACEPTIVE (CONDOM), Substantially Equivalent on 1990-06-06. Applicant: Guangzhou No. 11 Rubber Factory. Device class: 2.

Clearance details

Applicant: Guangzhou No. 11 Rubber Factory
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1989-10-24
Decision date: 1990-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Encinitas, CA, US

Download summary PDF View on FDA.gov ↗

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