SENSATIONS BRAND CONDOMS— 510(k) K871358

Name: FDA 510(k) clearance K871358
Creator: U.S. Food and Drug Administration
Published: 1989-03-01

Substantially Equivalent

Apex Medical Technologies, Inc.

FDA 510(k) clearance K871358 for SENSATIONS BRAND CONDOMS, Substantially Equivalent on 1989-03-01. 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: 1987-04-06
Decision date: 1989-03-01
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.