TRUSTEX COLA FLAVORD CONDOM— 510(k) K964598

Name: FDA 510(k) clearance K964598
Creator: U.S. Food and Drug Administration
Published: 1997-02-14

Substantially Equivalent

Line One Laboratories

FDA 510(k) clearance K964598 for TRUSTEX COLA FLAVORD CONDOM, Substantially Equivalent on 1997-02-14. Applicant: Line One Laboratories. Device class: 2.

Clearance details

Applicant: Line One Laboratories
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1996-11-18
Decision date: 1997-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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