PROPHYLACTIC (CONDOM)— 510(k) K854622

Substantially Equivalent

Medelec Intl. Corp.

FDA 510(k) clearance K854622 for PROPHYLACTIC (CONDOM), Substantially Equivalent on 1986-04-11. Applicant: Medelec Intl. Corp.. Device class: 2.

Clearance details

Applicant: Medelec Intl. Corp.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1985-11-18
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, 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.