Cleared Traditional

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.

K902305 · Armkel, LLC · Obstetrics & Gynecology
Mar 1991
Decision
311d
Days
Class 2
Risk

About This 510(k) Submission

K902305 is an FDA 510(k) clearance for the TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM., a Condom (Class II — Special Controls, product code HIS), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on March 29, 1991, 311 days after receiving the submission on May 22, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K902305 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1990
Decision Date March 29, 1991
Days to Decision 311 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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