PROPHYLACTIC (CONDOM) MR. JOHNNY— 510(k) K865106

Name: FDA 510(k) clearance K865106
Creator: U.S. Food and Drug Administration
Published: 1987-05-20

Substantially Equivalent

Medelec Intl. Corp.

FDA 510(k) clearance K865106 for PROPHYLACTIC (CONDOM) MR. JOHNNY, Substantially Equivalent on 1987-05-20. 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: 1986-12-31
Decision date: 1987-05-20
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.