STANDARD CONDOM— 510(k) K895530

Substantially Equivalent

Mayer Laboratories

FDA 510(k) clearance K895530 for STANDARD CONDOM, Substantially Equivalent on 1989-11-28. Applicant: Mayer Laboratories. Device class: 2.

Clearance details

Applicant: Mayer Laboratories
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1989-09-13
Decision date: 1989-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, 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.