Cleared Traditional

EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT

K902804 · Okamoto USA, Inc. · Obstetrics & Gynecology
Aug 1990
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K902804 is an FDA 510(k) clearance for the EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on August 13, 1990, 47 days after receiving the submission on June 27, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K902804 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1990
Decision Date August 13, 1990
Days to Decision 47 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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