LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE— 510(k) K931077

Name: FDA 510(k) clearance K931077
Creator: U.S. Food and Drug Administration
Published: 1994-09-14

Substantially Equivalent

J.K. Chemicals, Ltd.

FDA 510(k) clearance K931077 for LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE, Substantially Equivalent on 1994-09-14. Applicant: J.K. Chemicals, Ltd.. Device class: 2.

Clearance details

Applicant: J.K. Chemicals, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1993-03-03
Decision date: 1994-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, 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.