PROTEX, TAHITI CONDOM— 510(k) K860680

Substantially Equivalent

U. C. Import & Co.

FDA 510(k) clearance K860680 for PROTEX, TAHITI CONDOM, Substantially Equivalent on 1986-09-26. Applicant: U. C. Import & Co.. Device class: 2.

Clearance details

Applicant: U. C. Import & Co.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1986-02-25
Decision date: 1986-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, PA, 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.