Cleared Traditional

RUBBER CONTRACEPTIVE, LATEX CONDOMS

K875111 · Okamoto USA, Inc. · Obstetrics & Gynecology
Feb 1988
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K875111 is an FDA 510(k) clearance for the RUBBER CONTRACEPTIVE, LATEX CONDOMS, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Stratford, US). The FDA issued a Cleared decision on February 26, 1988, 74 days after receiving the submission on December 14, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K875111 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1987
Decision Date February 26, 1988
Days to Decision 74 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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