SPERMICIDAL LUBRICATED CONDOM— 510(k) K931220

Substantially Equivalent

Monsys USA, Inc.

FDA 510(k) clearance K931220 for SPERMICIDAL LUBRICATED CONDOM, Substantially Equivalent on 1996-05-22. Applicant: Monsys USA, Inc.. Device class: 2.

Clearance details

Applicant: Monsys USA, Inc.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1993-03-10
Decision date: 1996-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philippi, WV, 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.