MEGA BIG BOY CONDOM— 510(k) K140379

Substantially Equivalent

Okamoto USA, Inc.

FDA 510(k) clearance K140379 for MEGA BIG BOY CONDOM, Substantially Equivalent on 2014-07-01. Applicant: Okamoto USA, Inc..

Clearance details

Applicant: Okamoto USA, Inc.
Product code: Code HIS
Advisory panel: Obstetrics/Gynecology
Date received: 2014-02-14
Decision date: 2014-07-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

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