POLYURETHANE CONDOM— 510(k) K902936

Name: FDA 510(k) clearance K902936
Creator: U.S. Food and Drug Administration
Published: 1991-03-06

Substantially Equivalent

Apex Medical Technologies, Inc.

FDA 510(k) clearance K902936 for POLYURETHANE CONDOM, Substantially Equivalent on 1991-03-06. Applicant: Apex Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Apex Medical Technologies, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1990-07-03
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.