LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9— 510(k) K871304

Name: FDA 510(k) clearance K871304
Creator: U.S. Food and Drug Administration
Published: 1987-06-11

Substantially Equivalent

Ansell, Inc.

FDA 510(k) clearance K871304 for LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9, Substantially Equivalent on 1987-06-11. Applicant: Ansell, Inc.. Device class: 2.

Clearance details

Applicant: Ansell, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1987-04-01
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dothan, AL, 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.