MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS— 510(k) K980964

Name: FDA 510(k) clearance K980964
Creator: U.S. Food and Drug Administration
Published: 1999-03-12

Substantially Equivalent

Ls Rubber Sdn Bhd

FDA 510(k) clearance K980964 for MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS, Substantially Equivalent on 1999-03-12. Applicant: Ls Rubber Sdn Bhd. Device class: 2.

Clearance details

Applicant: Ls Rubber Sdn Bhd
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1998-03-16
Decision date: 1999-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, 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.