CONCEIVEX LATEX-FREE SEMEN COLLECTOR— 510(k) K080752

Name: FDA 510(k) clearance K080752
Creator: U.S. Food and Drug Administration
Published: 2008-05-14

Substantially Equivalent

Conceivex, Inc.

FDA 510(k) clearance K080752 for CONCEIVEX LATEX-FREE SEMEN COLLECTOR, Substantially Equivalent on 2008-05-14. Applicant: Conceivex, Inc.. Device class: 2.

Clearance details

Applicant: Conceivex, Inc.
Product code: Code OBB
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 2008-03-17
Decision date: 2008-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Mt. Airy, MD, 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.