Cleared Traditional

K895640 - MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
(FDA 510(k) Clearance)

K895640 · Armkel, LLC · Obstetrics & Gynecology

Jan 1990

Decision

126d

Days

Class 2

Risk

K895640 is an FDA 510(k) clearance for the MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT, a Condom (Class II — Special Controls, product code HIS), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on January 23, 1990, 126 days after receiving the submission on September 19, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K895640 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 1989
Decision Date	January 23, 1990
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—