Cleared Traditional

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM

K896339 · Okamoto USA, Inc. · Obstetrics & Gynecology
Jan 1990
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K896339 is an FDA 510(k) clearance for the MODIFIED LABELING ON OKAMOTO HARMONY CONDOM, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on January 10, 1990, 68 days after receiving the submission on November 3, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K896339 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1989
Decision Date January 10, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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