LUBRICATED BAGGY TACTYLON CONDOM— 510(k) K974121

Name: FDA 510(k) clearance K974121
Creator: U.S. Food and Drug Administration
Published: 1998-01-29

Substantially Equivalent

Sensicon Corp.

FDA 510(k) clearance K974121 for LUBRICATED BAGGY TACTYLON CONDOM, Substantially Equivalent on 1998-01-29. Applicant: Sensicon Corp.. Device class: 2.

Clearance details

Applicant: Sensicon Corp.
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1997-10-31
Decision date: 1998-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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