TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR— 510(k) K904000

Name: FDA 510(k) clearance K904000
Creator: U.S. Food and Drug Administration
Published: 1991-02-19

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K904000 for TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR, Substantially Equivalent on 1991-02-19. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1990-08-29
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, 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.