Cleared Traditional

EXTRA STRENGTH SKIN LESS SKIN CONDOM

K884402 · Okamoto USA, Inc. · Obstetrics & Gynecology
Mar 1989
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K884402 is an FDA 510(k) clearance for the EXTRA STRENGTH SKIN LESS SKIN CONDOM, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 10, 1989, 142 days after receiving the submission on October 19, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K884402 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1988
Decision Date March 10, 1989
Days to Decision 142 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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